Dermatitis Atopic
Conditions
Brief summary
Primary Objective: \- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate to severe atopic dermatitis (AD) treated with dupilumab. Secondary Objectives: * Evaluate changes in skin barrier function with TEWL assessed after STS in predefined lesional and non-lesional skin in pediatric participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. * Evaluate time course of change in skin barrier function with TEWL assessed before and after STS in predefined lesional and non-lesional skin in pediatric participants with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers.
Detailed description
Total study duration including screening and follow-up was 32 weeks.
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
: * Participant must be between \>=6 to \<12 years of age (inclusive), at the time of signing the informed consent * 15 kg \<= body weight \<60 kg. Atopic dermatitis participants: * Male or female pediatric participants. * Participants with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. * Investigator Global Assessment (IGA) score of \>=3 (for US participants) or IGA \>=4 (for EU participants) at screening (on the 0-4 scale) depending on approved label indication in the country. * Participants with moderate to severe AD those were eligible to be treated with dupilumab according to product label. * Participants with AD must have had active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation \>=2 at screening on the 0-3 scale of the Individual Signs Score. * Participants should have had a non-lesional (normal looking) skin area 4 centimeter (cm) from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it was acceptable to identify normal looking skin as close to the lesion as possible. Healthy volunteers: \- Age and gender matched (match on age ±2 years) to a selected AD participant by study site.
Exclusion criteria
* Previous treatment with dupilumab within 6 months prior to screening. * Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (i.e., skin atrophy, ichthyosis, tinea infection, contact dermatitis). * Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that was adequate for TEWL assessments. * Hypersensitivity to the active substance or to any of the excipients of dupilumab. * Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren's syndrome, keratoconjunctivitis sicca, or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine. * Healthy volunteers with a personal history of an atopic condition. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that was used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM |
| Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline ('predefined skin area'). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM. |
| Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS (nsts) used to reflect the overall integrity of stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM. |
| Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS reflect the overall integrity of the stratum corneum. Non-LS areas for TEWL assessment & STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before & after 5, 10, 15 &20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM. |
| Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Non-LS areas for TEWL assessment and STS were identified at baseline(predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10,15 and 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline(Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM. |
| Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over a defined number of STS used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment & STS were identified at baseline(predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10,15 & 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC: composite measure before & after 5, 10, 15& 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM. |
| Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Normal skin areas for TEWL assessment and STS identified at baseline(predefined skin area). Within predefined Normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS and after 5, 10,15 and 20 STS on pre-defined Normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10,15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM. |
| Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participant were reported in this OM. |
| Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | Baseline, Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at Baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM. |
| Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on the first spot. Absolute change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM. |
| Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM. |
| Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | Baseline, Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participants were reported in this OM. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Study was conducted at 3 active sites in the United States and United Kingdom. A total of 43 participants were screened between 19 Feb 2021 and 12 May 2022, out of which 41 were enrolled and 2 were screen failures due to not meeting inclusion criteria.
Pre-assignment details
Healthy volunteer's cohort received no treatment and was considered as a reference comparator group.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants. | 18 |
| Atopic Dermatitis Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14. | 23 |
| Total | 41 |
Baseline characteristics
| Characteristic | Atopic Dermatitis Participants | Total | Healthy Volunteers |
|---|---|---|---|
| Age, Continuous | 7.8 years STANDARD_DEVIATION 1.6 | 8.0 years STANDARD_DEVIATION 1.7 | 8.2 years STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 25 Participants | 9 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 15 Participants | 25 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 23 |
| other Total, other adverse events | 6 / 18 | 21 / 23 |
| serious Total, serious adverse events | 0 / 18 | 0 / 23 |
Outcome results
Primary
Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM).
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for Healthy Volunteer arm as pre-specified in protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16 | -38.5633 percent change | Standard Deviation 27.1211 |
Secondary
Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS (nsts) used to reflect the overall integrity of stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Day 57 | -632.0224 nsts*grams per square meter per hour | Standard Deviation 494.4981 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Day 113 | -608.1875 nsts*grams per square meter per hour | Standard Deviation 601.7999 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Day 197 | -659.4033 nsts*grams per square meter per hour | Standard Deviation 570.2425 |
Secondary
Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Non-LS areas for TEWL assessment and STS were identified at baseline(predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10,15 and 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline(Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Day 57 | -281.9579 nsts*grams per square meter per hour | Standard Deviation 342.1271 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Day 113 | -217.7544 nsts*grams per square meter per hour | Standard Deviation 462.0173 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Day 197 | -367.5469 nsts*grams per square meter per hour | Standard Deviation 340.1948 |
Secondary
Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Normal skin areas for TEWL assessment and STS identified at baseline(predefined skin area). Within predefined Normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS and after 5, 10,15 and 20 STS on pre-defined Normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10,15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Day 57 | 16.8563 nsts*grams per square meter per hour | Standard Deviation 70.4582 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Day 113 | 2.5568 nsts*grams per square meter per hour | Standard Deviation 197.8379 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Day 197 | -72.9050 nsts*grams per square meter per hour | Standard Deviation 108.823 |
Secondary
Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | -33.1024 grams per square meter per hour | Standard Deviation 36.2286 |
Secondary
Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | -10.9488 grams per square meter per hour | Standard Deviation 31.13 |
Secondary
Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | -1.3482 grams per square meter per hour | Standard Deviation 6.6778 |
Secondary
Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | -33.4028 grams per square meter per hour | Standard Deviation 31.1957 |
Secondary
Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | -12.6576 grams per square meter per hour | Standard Deviation 30.0412 |
Secondary
Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | 0.1082 grams per square meter per hour | Standard Deviation 17.5865 |
Secondary
Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that was used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | -35.6671 grams per square meter per hour | Standard Deviation 31.2267 |
Secondary
Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16 | -13.6682 grams per square meter per hour | Standard Deviation 33.3065 |
Secondary
Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | 5.9327 grams per square meter per hour | Standard Deviation 32.0123 |
Secondary
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 57 | -31.3795 grams per square meter per hour | Standard Deviation 25.4943 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 113 | -31.1761 grams per square meter per hour | Standard Deviation 31.342 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 57 | -37.9779 grams per square meter per hour | Standard Deviation 23.3049 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 197 | -33.5753 grams per square meter per hour | Standard Deviation 40.1857 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 57 | -36.4267 grams per square meter per hour | Standard Deviation 31.1758 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 113 | -33.1024 grams per square meter per hour | Standard Deviation 36.2286 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 197 | -35.8254 grams per square meter per hour | Standard Deviation 33.3362 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 113 | -33.4028 grams per square meter per hour | Standard Deviation 31.1957 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 197 | -36.0843 grams per square meter per hour | Standard Deviation 27.5612 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 57 | -35.0726 grams per square meter per hour | Standard Deviation 23.5765 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 113 | -35.6671 grams per square meter per hour | Standard Deviation 31.2267 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 197 | -34.5257 grams per square meter per hour | Standard Deviation 23.9001 |
Secondary
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 5 STS: Day 57 | 0.5642 grams per square meter per hour | Standard Deviation 3.3355 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 5 STS: Day 113 | -1.0255 grams per square meter per hour | Standard Deviation 4.3657 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 5 STS: Day 197 | -1.5627 grams per square meter per hour | Standard Deviation 5.2934 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 10 STS: Day 57 | 0.2825 grams per square meter per hour | Standard Deviation 4.5142 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 10 STS: Day 113 | -1.3482 grams per square meter per hour | Standard Deviation 6.6778 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 10 STS: Day 197 | -3.0880 grams per square meter per hour | Standard Deviation 5.2754 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 15 STS: Day 57 | 0.4750 grams per square meter per hour | Standard Deviation 6.4442 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 15 STS: Day 113 | 0.1082 grams per square meter per hour | Standard Deviation 17.5865 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 15 STS: Day 197 | -5.8847 grams per square meter per hour | Standard Deviation 8.1968 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 20 STS: Day 57 | 3.4683 grams per square meter per hour | Standard Deviation 9.8235 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 20 STS: Day 113 | 5.9327 grams per square meter per hour | Standard Deviation 32.0123 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 20 STS: Day 197 | -7.4760 grams per square meter per hour | Standard Deviation 9.3514 |
Secondary
Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16 | -9.0771 grams per square meter per hour | Standard Deviation 21.3022 |
Secondary
Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | -1.0255 grams per square meter per hour | Standard Deviation 4.3657 |
Secondary
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 1 | -9.3486 grams per square meter per hour | Standard Deviation 21.2256 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 2 | -6.0491 grams per square meter per hour | Standard Deviation 17.581 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 3 | -3.1965 grams per square meter per hour | Standard Deviation 14.464 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 1 | -15.4336 grams per square meter per hour | Standard Deviation 25.0975 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 2 | -9.8073 grams per square meter per hour | Standard Deviation 19.7385 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 3 | -7.6682 grams per square meter per hour | Standard Deviation 21.9239 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 1 | -23.0157 grams per square meter per hour | Standard Deviation 26.8847 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 2 | -20.7186 grams per square meter per hour | Standard Deviation 23.4149 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 3 | -15.6557 grams per square meter per hour | Standard Deviation 20.1212 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 1 | -23.9585 grams per square meter per hour | Standard Deviation 21.7106 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 2 | -21.2010 grams per square meter per hour | Standard Deviation 21.2593 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 3 | -17.9170 grams per square meter per hour | Standard Deviation 19.731 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 1 | -27.0535 grams per square meter per hour | Standard Deviation 28.0249 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 2 | -24.5188 grams per square meter per hour | Standard Deviation 25.6684 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 3 | -20.7018 grams per square meter per hour | Standard Deviation 22.5936 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 1 | -25.1221 grams per square meter per hour | Standard Deviation 27.021 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 2 | -24.2358 grams per square meter per hour | Standard Deviation 24.6028 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 3 | -20.3379 grams per square meter per hour | Standard Deviation 20.3751 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 1 | -29.1917 grams per square meter per hour | Standard Deviation 24.3114 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 2 | -24.4494 grams per square meter per hour | Standard Deviation 24.2054 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 3 | -23.1056 grams per square meter per hour | Standard Deviation 20.4692 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 1 | -24.6678 grams per square meter per hour | Standard Deviation 27.8013 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 2 | -23.2878 grams per square meter per hour | Standard Deviation 26.567 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 3 | -17.9028 grams per square meter per hour | Standard Deviation 22.2483 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 1 | -28.2564 grams per square meter per hour | Standard Deviation 29.2212 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 2 | -18.7786 grams per square meter per hour | Standard Deviation 31.4917 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 3 | -19.8921 grams per square meter per hour | Standard Deviation 27.852 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 1 | -27.4493 grams per square meter per hour | Standard Deviation 33.708 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 2 | -22.5607 grams per square meter per hour | Standard Deviation 31.7696 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 3 | -22.0860 grams per square meter per hour | Standard Deviation 27.1286 |
Secondary
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 1 | 4.1752 grams per square meter per hour | Standard Deviation 14.1047 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 2 | -0.0248 grams per square meter per hour | Standard Deviation 11.8585 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 3 | -0.3413 grams per square meter per hour | Standard Deviation 9.8571 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 1 | 0.4723 grams per square meter per hour | Standard Deviation 9.7975 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 2 | -2.6176 grams per square meter per hour | Standard Deviation 13.1001 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 3 | -1.0171 grams per square meter per hour | Standard Deviation 11.3877 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 1 | -3.8162 grams per square meter per hour | Standard Deviation 10.3046 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 2 | -3.5735 grams per square meter per hour | Standard Deviation 16.4593 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 3 | -5.3314 grams per square meter per hour | Standard Deviation 12.8392 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 1 | -5.3400 grams per square meter per hour | Standard Deviation 10.8674 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 2 | -6.7411 grams per square meter per hour | Standard Deviation 13.5999 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 3 | -9.5905 grams per square meter per hour | Standard Deviation 14.0754 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 1 | -6.7424 grams per square meter per hour | Standard Deviation 9.7834 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 2 | -8.8444 grams per square meter per hour | Standard Deviation 12.4876 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 3 | -10.5600 grams per square meter per hour | Standard Deviation 14.1984 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 1 | -8.2874 grams per square meter per hour | Standard Deviation 8.5546 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 2 | -9.7772 grams per square meter per hour | Standard Deviation 11.7879 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 3 | -11.9179 grams per square meter per hour | Standard Deviation 13.1662 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 1 | -8.2272 grams per square meter per hour | Standard Deviation 11.6158 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 2 | -7.6171 grams per square meter per hour | Standard Deviation 16.1511 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 3 | -13.1811 grams per square meter per hour | Standard Deviation 14.4647 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 1 | -8.0665 grams per square meter per hour | Standard Deviation 11.997 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 2 | -9.2906 grams per square meter per hour | Standard Deviation 13.7202 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 3 | -11.2776 grams per square meter per hour | Standard Deviation 12.9322 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 1 | -7.0229 grams per square meter per hour | Standard Deviation 15.4066 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 2 | -7.0408 grams per square meter per hour | Standard Deviation 12.8562 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 3 | -10.4414 grams per square meter per hour | Standard Deviation 14.5146 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 1 | -8.9200 grams per square meter per hour | Standard Deviation 11.3266 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 2 | -11.2953 grams per square meter per hour | Standard Deviation 15.3452 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 3 | -11.1625 grams per square meter per hour | Standard Deviation 16.2087 |
Secondary
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 1 | -0.2508 grams per square meter per hour | Standard Deviation 4.8798 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 2 | -1.8215 grams per square meter per hour | Standard Deviation 3.3907 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 3 | -0.7869 grams per square meter per hour | Standard Deviation 2.9791 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 1 | -0.5786 grams per square meter per hour | Standard Deviation 3.3947 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 2 | -1.0029 grams per square meter per hour | Standard Deviation 3.432 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 3 | -0.3829 grams per square meter per hour | Standard Deviation 3.3925 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 1 | -0.7575 grams per square meter per hour | Standard Deviation 3.2991 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 2 | 1.0233 grams per square meter per hour | Standard Deviation 3.7207 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 3 | 0.6433 grams per square meter per hour | Standard Deviation 2.0759 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 1 | -1.1631 grams per square meter per hour | Standard Deviation 3.1429 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 2 | 0.8585 grams per square meter per hour | Standard Deviation 1.8609 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 3 | 0.7938 grams per square meter per hour | Standard Deviation 1.7624 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 1 | -1.0129 grams per square meter per hour | Standard Deviation 4.094 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 2 | -0.8357 grams per square meter per hour | Standard Deviation 4.7103 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 3 | 0.7057 grams per square meter per hour | Standard Deviation 5.1247 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 1 | 0.6308 grams per square meter per hour | Standard Deviation 4.1304 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 2 | 0.2283 grams per square meter per hour | Standard Deviation 2.6839 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 3 | 1.5142 grams per square meter per hour | Standard Deviation 4.1943 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 1 | 0.0164 grams per square meter per hour | Standard Deviation 3.2348 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 2 | -0.3221 grams per square meter per hour | Standard Deviation 3.546 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 3 | 0.2779 grams per square meter per hour | Standard Deviation 3.8491 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 1 | -0.3791 grams per square meter per hour | Standard Deviation 3.4231 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 2 | 0.4882 grams per square meter per hour | Standard Deviation 2.5528 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 3 | 2.0527 grams per square meter per hour | Standard Deviation 2.1762 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 1 | -0.9293 grams per square meter per hour | Standard Deviation 6.5972 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 2 | 0.6880 grams per square meter per hour | Standard Deviation 3.7653 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 3 | 0.4793 grams per square meter per hour | Standard Deviation 4.5057 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 1 | -0.6153 grams per square meter per hour | Standard Deviation 4.8187 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 2 | -0.0427 grams per square meter per hour | Standard Deviation 3.656 |
| Atopic Dermatitis Participants | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 3 | 0.6747 grams per square meter per hour | Standard Deviation 4.8536 |
Secondary
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Day 57 | -38.2091 percent change | Standard Deviation 25.6654 |
| Atopic Dermatitis Participants | Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Day 113 | -34.0025 percent change | Standard Deviation 29.1866 |
| Atopic Dermatitis Participants | Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | Day 197 | -40.0143 percent change | Standard Deviation 26.9737 |
Secondary
Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS reflect the overall integrity of the stratum corneum. Non-LS areas for TEWL assessment & STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before & after 5, 10, 15 &20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Day 57 | -21.7570 percent change | Standard Deviation 29.1137 |
| Atopic Dermatitis Participants | Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Day 113 | -10.8940 percent change | Standard Deviation 50.7679 |
| Atopic Dermatitis Participants | Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | Day 197 | -28.6897 percent change | Standard Deviation 26.0253 |
Secondary
Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over a defined number of STS used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment & STS were identified at baseline(predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10,15 & 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC: composite measure before & after 5, 10, 15& 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Day 57 | 3.2794 percent change | Standard Deviation 15.6493 |
| Atopic Dermatitis Participants | Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Day 113 | 3.4753 percent change | Standard Deviation 30.2504 |
| Atopic Dermatitis Participants | Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | Day 197 | -10.1582 percent change | Standard Deviation 18.4753 |
Secondary
Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | -34.7741 percent change | Standard Deviation 31.0541 |
Secondary
Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | -3.8193 percent change | Standard Deviation 74.6263 |
Secondary
Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | 0.7091 percent change | Standard Deviation 25.0615 |
Secondary
Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | -33.3119 percent change | Standard Deviation 32.7125 |
Secondary
Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | -7.6067 percent change | Standard Deviation 54.7945 |
Secondary
Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participants arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | 4.5364 percent change | Standard Deviation 42.7525 |
Secondary
Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at Baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | -33.1336 percent change | Standard Deviation 28.1613 |
Secondary
Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16 | -6.1452 percent change | Standard Deviation 67.9496 |
Secondary
Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | 13.2578 percent change | Standard Deviation 64.388 |
Secondary
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participant were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 57 | -42.2019 percent change | Standard Deviation 22.5314 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 113 | -38.5633 percent change | Standard Deviation 27.1211 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 197 | -36.4601 percent change | Standard Deviation 47.5902 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 57 | -40.4595 percent change | Standard Deviation 27.4572 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 113 | -34.7741 percent change | Standard Deviation 31.0541 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 197 | -39.9440 percent change | Standard Deviation 29.2084 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 57 | -41.6561 percent change | Standard Deviation 24.096 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 113 | -33.3119 percent change | Standard Deviation 32.7125 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 197 | -38.4286 percent change | Standard Deviation 27.0978 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 57 | -34.8297 percent change | Standard Deviation 23.052 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 113 | -33.1336 percent change | Standard Deviation 28.1613 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 197 | -35.6561 percent change | Standard Deviation 23.0987 |
Secondary
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 57 | -24.8218 percent change | Standard Deviation 31.4633 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 197 | -29.7635 percent change | Standard Deviation 44.0691 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 57 | -20.3640 percent change | Standard Deviation 43.5318 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 113 | -3.8193 percent change | Standard Deviation 74.6263 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 197 | -29.6888 percent change | Standard Deviation 38.9536 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 57 | -18.4348 percent change | Standard Deviation 33.3647 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 113 | -7.6067 percent change | Standard Deviation 54.7945 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 197 | -27.2268 percent change | Standard Deviation 25.158 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 57 | -19.2584 percent change | Standard Deviation 30.1343 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 113 | -6.1452 percent change | Standard Deviation 67.9496 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 197 | -22.3311 percent change | Standard Deviation 23.0908 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 113 | -4.8842 percent change | Standard Deviation 70.567 |
Secondary
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 5 STS: Day 57 | 4.9595 percent change | Standard Deviation 16.095 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 5 STS: Day 113 | 1.4464 percent change | Standard Deviation 26.7257 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 5 STS: Day 197 | -1.6729 percent change | Standard Deviation 25.2293 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 10 STS: Day 57 | 4.0996 percent change | Standard Deviation 20.4647 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 10 STS: Day 113 | 0.7091 percent change | Standard Deviation 25.0615 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 10 STS: Day 197 | -7.4475 percent change | Standard Deviation 19.7215 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 15 STS: Day 57 | 3.2339 percent change | Standard Deviation 20.9086 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 15 STS: Day 113 | 4.5364 percent change | Standard Deviation 42.7525 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 15 STS: Day 197 | -14.0103 percent change | Standard Deviation 18.5552 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 20 STS: Day 57 | 4.3494 percent change | Standard Deviation 27.5527 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 20 STS: Day 113 | 13.2578 percent change | Standard Deviation 64.388 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | After 20 STS: Day 197 | -18.0480 percent change | Standard Deviation 22.6193 |
Secondary
Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16 | -4.8842 percent change | Standard Deviation 70.567 |
Secondary
Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Week 16
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis arm as pre-specified in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | 1.4464 percent change | Standard Deviation 26.7257 |
Secondary
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline ('predefined skin area'). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 1 | -7.1596 percent change | Standard Deviation 36.6637 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 2 | -6.3439 percent change | Standard Deviation 33.8145 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 3 | -7.0747 percent change | Standard Deviation 28.3554 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 1 | -15.3096 percent change | Standard Deviation 45.6163 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 2 | -11.0740 percent change | Standard Deviation 35.5483 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 3 | -8.1780 percent change | Standard Deviation 44.9382 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 1 | -30.3070 percent change | Standard Deviation 33.6643 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 2 | -29.1730 percent change | Standard Deviation 31.7167 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 3 | -27.0015 percent change | Standard Deviation 25.8528 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 1 | -37.8349 percent change | Standard Deviation 24.7709 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 2 | -33.0139 percent change | Standard Deviation 27.856 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 3 | -32.7080 percent change | Standard Deviation 28.8445 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 1 | -37.8675 percent change | Standard Deviation 29.0275 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 2 | -36.1625 percent change | Standard Deviation 28.9829 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 3 | -32.9996 percent change | Standard Deviation 33.2028 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 1 | -38.2449 percent change | Standard Deviation 40.0558 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 2 | -39.3104 percent change | Standard Deviation 27.6888 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 3 | -35.8992 percent change | Standard Deviation 27.9526 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 1 | -45.6060 percent change | Standard Deviation 23.2839 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 2 | -40.8609 percent change | Standard Deviation 30.8002 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 3 | -41.1371 percent change | Standard Deviation 24.5842 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 1 | -36.0863 percent change | Standard Deviation 33.7259 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 2 | -37.4815 percent change | Standard Deviation 30.8507 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 3 | -32.3491 percent change | Standard Deviation 29.2966 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 1 | -40.9536 percent change | Standard Deviation 30.9966 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 2 | -20.8463 percent change | Standard Deviation 50.6518 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 3 | -31.3185 percent change | Standard Deviation 42.0614 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 1 | -35.2305 percent change | Standard Deviation 45.8818 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 2 | -30.3358 percent change | Standard Deviation 48.3028 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 3 | -36.5267 percent change | Standard Deviation 37.723 |
Secondary
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 1 | 41.0825 percent change | Standard Deviation 91.3744 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 2 | 13.5236 percent change | Standard Deviation 49.3733 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 3 | 9.7943 percent change | Standard Deviation 43.9272 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 1 | 19.0612 percent change | Standard Deviation 58.1703 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 2 | 9.6866 percent change | Standard Deviation 52.6831 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 3 | 13.2574 percent change | Standard Deviation 55.8095 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 1 | -3.9277 percent change | Standard Deviation 35.988 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 2 | 8.9306 percent change | Standard Deviation 70.2617 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 3 | 0.4973 percent change | Standard Deviation 49.5636 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 1 | -8.9585 percent change | Standard Deviation 39.0443 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 2 | -10.5728 percent change | Standard Deviation 35.2672 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 3 | -13.0407 percent change | Standard Deviation 44.5264 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 1 | -15.6919 percent change | Standard Deviation 29.7995 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 2 | -21.6885 percent change | Standard Deviation 30.1255 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 3 | -16.2025 percent change | Standard Deviation 42.7984 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 1 | -24.5008 percent change | Standard Deviation 26.9801 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 2 | -27.6040 percent change | Standard Deviation 23.0969 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 3 | -25.7321 percent change | Standard Deviation 33.131 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 1 | -21.9316 percent change | Standard Deviation 34.362 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 2 | -16.7008 percent change | Standard Deviation 62.4384 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 3 | -29.2721 percent change | Standard Deviation 40.0673 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 1 | -20.4359 percent change | Standard Deviation 42.6948 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 2 | -23.1303 percent change | Standard Deviation 41.2717 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 3 | -27.4981 percent change | Standard Deviation 33.5326 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 1 | -6.7535 percent change | Standard Deviation 73.4261 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 2 | -16.3903 percent change | Standard Deviation 41.9864 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 3 | -19.3970 percent change | Standard Deviation 46.5302 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 1 | -23.3812 percent change | Standard Deviation 39.5978 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 2 | -27.3104 percent change | Standard Deviation 32.8267 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 3 | -22.1813 percent change | Standard Deviation 40.5124 |
Secondary
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM.
Time frame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 1 | 5.0103 percent change | Standard Deviation 39.417 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 2 | -8.7688 percent change | Standard Deviation 20.5764 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 8 - Spot 3 | -3.8203 percent change | Standard Deviation 19.516 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 1 | 1.9837 percent change | Standard Deviation 27.7012 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 2 | -4.0758 percent change | Standard Deviation 22.1886 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 15 - Spot 3 | -1.7489 percent change | Standard Deviation 21.1652 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 1 | -2.6655 percent change | Standard Deviation 19.8558 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 2 | 7.5939 percent change | Standard Deviation 22.7859 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 22 - Spot 3 | 3.8603 percent change | Standard Deviation 12.1068 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 1 | -1.7648 percent change | Standard Deviation 21.482 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 2 | 9.9969 percent change | Standard Deviation 14.4219 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 29 - Spot 3 | 8.4098 percent change | Standard Deviation 15.2499 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 1 | 1.4115 percent change | Standard Deviation 27.8012 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 2 | 2.9668 percent change | Standard Deviation 30.1272 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 43 - Spot 3 | 13.4093 percent change | Standard Deviation 35.9985 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 1 | 7.6533 percent change | Standard Deviation 24.0747 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 2 | 5.3384 percent change | Standard Deviation 17.9065 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 57 - Spot 3 | 12.6926 percent change | Standard Deviation 24.7125 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 1 | 5.2021 percent change | Standard Deviation 23.1397 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 2 | 0.7096 percent change | Standard Deviation 19.5448 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 85 - Spot 3 | 5.1021 percent change | Standard Deviation 20.069 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 1 | 2.6054 percent change | Standard Deviation 26.2241 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 2 | 9.4234 percent change | Standard Deviation 24.1533 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 113 - Spot 3 | 17.0905 percent change | Standard Deviation 16.4596 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 1 | 10.3105 percent change | Standard Deviation 52.8138 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 2 | 11.2398 percent change | Standard Deviation 22.7028 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 155 - Spot 3 | 11.5842 percent change | Standard Deviation 27.2298 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 1 | 3.3636 percent change | Standard Deviation 26.94 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 2 | 5.3772 percent change | Standard Deviation 19.9583 |
| Atopic Dermatitis Participants | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | Day 197 - Spot 3 | 12.0900 percent change | Standard Deviation 24.869 |
Secondary
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197
TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on the first spot. Absolute change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM.
Time frame: Baseline, Days 57, 113 and 197
Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 113 | -10.9488 grams per square meter per hour | Standard Deviation 31.13 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 197 | -21.2825 grams per square meter per hour | Standard Deviation 23.2998 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 57 | -16.1047 grams per square meter per hour | Standard Deviation 26.4807 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 113 | -12.6576 grams per square meter per hour | Standard Deviation 30.0412 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 15 STS: Day 197 | -21.9006 grams per square meter per hour | Standard Deviation 19.2885 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 57 | -18.5800 grams per square meter per hour | Standard Deviation 30.3574 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 113 | -13.6682 grams per square meter per hour | Standard Deviation 33.3065 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 57 | -11.8526 grams per square meter per hour | Standard Deviation 12.618 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 113 | -9.0771 grams per square meter per hour | Standard Deviation 21.3022 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 5 STS: Day 197 | -15.8375 grams per square meter per hour | Standard Deviation 18.0369 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 10 STS: Day 57 | -15.0005 grams per square meter per hour | Standard Deviation 20.1721 |
| Atopic Dermatitis Participants | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | After 20 STS: Day 197 | -20.0575 grams per square meter per hour | Standard Deviation 16.1537 |