Dupilumab Skin Barrier Function Study in Atopic Dermatitis

Open Label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Patients With Moderate to Severe Atopic Dermatitis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04447417

Acronym

BALISTAD

Enrollment

Registered

2020-06-25

Start date

2020-07-16

Completion date

2021-06-17

Last updated

2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

Primary Objective: \- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in 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 pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. * Evaluate time course of skin barrier function with TEWL assessed before and after STS in pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.

Detailed description

The duration for each participant was a total of approximately 24 weeks.

Interventions

DRUGDupilumab SAR231893

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

: \- Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent. Atopic dermatitis participants: * Male or female participants. * Participants with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. * Investigator Global Assessment score of \>=3 at screening (on the 0-4 scale). * Participants with moderate to severe atopic dermatitis that were eligible to be treated with dupilumab according to product monograph. * Participants with AD must have had active lesions on the upper limbs or lower limbs, with severity for lesion erythema or edema/papulation \>=2 at screening on the 0-3 scale of the individual signs score. * Patients must have had a non-lesional (normal looking) skin area 4 centimeters from the edge of the lesional area. * Were willing to refrain from applying any topical medication products on the target assessment areas (including lesional and non-lesional) throughout the study unless necessary to alleviate intolerable symptoms. * Were willing to refrain taking showers or soaking in a bathtub with soaps and body washes within 6 hours before TEWL assessments. * Were willing to apply Cetaphil or Vanicream moisturizer up to twice a day with an exception of moisturizer application on the targeted assessment areas (lesional and non-lesional areas) during the entire study from Day -7 to end of treatment. * Were willing and able to comply with all clinic visits and study-related procedures. Healthy volunteers: * Age and gender matched to a selected AD participant. Adolescents aged 12 to 17 years matched by post puberty status, and adults aged 18 to 65 years were matched by age as close as possible within 10 years of age. * No current dermatologic or systemic condition that could interfere with the assessments. * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of understanding and giving signed informed consent/assent as were described in the protocol, which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents \>=12 and \<18 years of age a specific ICF must also be signed by the participant's legally authorized representative.

Exclusion criteria

* 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, Netherton syndrome, severe photo damage). * 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 dry eye syndrome that required daily use of supplemental lubrication; or individuals with ocular conditions that required the use of ocular corticosteroids or cyclosporine. * Systemic AD treatment or phototherapy within 4 weeks of Baseline. * Topical AD treatment within 1 week of Baseline. Face and neck may be treated with topical steroids during the washout period if approved by the investigator. * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study. Examples included, but were not limited to participants with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c \>=9%), participants with cardiovascular conditions (eg, Class III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, participants on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric (known suicidal intentions) or lymphatic diseases. The specific justification for participants excluded under this criterion were noted in study documents (chart notes, electronic case report forms, screening logs, etc.). * History of hypersensitivity reaction to tape or adhesives. * Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) prior to Day 1, whichever was longer. * Current participation in another investigational clinical study. * Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who were legally institutionalized. * Participants were dependent on the Sponsor or Investigator (in conjunction with section 1.61 of the ICH-GCP Ordinance E6). * Individuals directly involved in the conduct of the study, or immediate family members of such individuals. * Any specific situation during study implementation/course that might rise ethics considerations. * Planned or anticipated major surgical procedure during the participant's participation in this study. * Pregnant or breast feeding women, or were planning to become pregnant or breastfeed during the participant's participation in this study. * Women unwilling to use adequate birth control, if of reproductive potential\* and sexually active. Adequate birth control was defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 weeks after last dose of study drug. These included condom, spermicide, hormonal contraceptives, intrauterine device, or double barrier contraception (i.e., condom + diaphragm) or a male partner with documented vasectomy. Additional requirements for acceptable contraception might apply in certain countries, based on local regulations. Investigators in these countries were notified accordingly in a protocol clarification letter. \*For females, menopause was defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of \>=25 milliunits per milliliter must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions were not required to use additional contraception. * Healthy volunteers with a personal history of an atopic condition. * Healthy volunteers with use of any topical treatment anywhere except Cetaphil or Vanicream moisturizer on non-targeted skin areas. 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 After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients 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 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 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). Here, overall number of participants analyzed=participants evaluable for this OM.

Secondary

Measure	Time frame	Description
Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS and 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 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 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 and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 and non-LS (first spot) in AD participants were reported in this OM.
Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 15 STS on LS and 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 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 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 and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 10 STS on LS and non-LS (first spot) in AD participants were reported in this OM.
Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 10 STS on LS and 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 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 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.
Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients 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 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 5 STS on LS (first spot) in AD participants were reported in this OM.
Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients 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 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 Patients 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 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 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 20 STS on LS and non-LS (first spot) in AD participants 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 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 and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	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 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, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	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 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, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and Week 16	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. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and Week 16	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. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on LS and non-LS 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 Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and 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, 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 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on normal skin 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 Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and 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, 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 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and 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. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. 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 rule. Percent change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM.
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and Week 16	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 was used to reflect overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. 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 rule. Absolute change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM. Expanded unit of measure is number of skin tape stripping\*grams per square meter per hour.
Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and 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. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots 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 rule. Percent Change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM.
Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Baseline, Day 15, 29, 57, 85 and 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. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots 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 rule. Absolute change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM. Expanded unit of measure is number of skin tape stripping\*grams per square meter per hour.
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 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.

Countries

Canada, United States

Participant flow

Recruitment details

Study was conducted at 2 centers in the United States and Canada. A total of 52 eligible participants were enrolled between 16 July 2020 and 19 January 2021 under the AD participants cohort or the healthy volunteers cohort.

Pre-assignment details

Healthy volunteer's cohort received no treatment and was considered as a reference comparator group.

Participants by arm

Arm	Count
Healthy Volunteer Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to a selected atopic dermatitis (AD) participants, received no treatment, but were monitored in similar way as AD participants.	26
Atopic Dermatitis Patients Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).	26
Total Title	52
Total	104

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Failure to meet inclusion criteria	1
Overall Study	Lost to Follow-up	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Healthy Volunteer	Atopic Dermatitis Patients	Total Title
Age, Continuous	33.4 years STANDARD_DEVIATION 16.4	32.2 years STANDARD_DEVIATION 17.2	32.8 years STANDARD_DEVIATION 16.7
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Black or African American	4 Participants	2 Participants	6 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	21 Participants	21 Participants	42 Participants
Sex: Female, Male Female	11 Participants	11 Participants	22 Participants
Sex: Female, Male Male	15 Participants	15 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 26
other Total, other adverse events	13 / 26	20 / 26
serious Total, serious adverse events	0 / 26	0 / 26

Outcome results

Primary

Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients 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 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 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). Here, overall number of participants analyzed=participants evaluable for this OM.

Time frame: Baseline, Week 16

Population: Modified intent-to-treat (mITT) population: all enrolled AD participants who received at least 1 dose of investigational medicinal product (IMP) and all enrolled healthy volunteers who had at least 1 TEWL/STS assessment performed, irrespective of compliance with protocol and procedures. If prohibited therapies used for AD, only visits prior to rescue treatment were considered. 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 Patients	Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16	-54.6 percent change	Standard Deviation 18

Comparison: TEWL data for linear mixed model was log-transformed to account for right skewness of data and heteroskedasticity. The linear mixed effect on log (TEWL) included age, sex, number of STS, localization on the body, visit, number of STS-by-visit interaction and number of STS-by-age interaction as fixed effects. Model was run on data on lesional skin area.p-value: <=0.000190% CI: [0.37, 0.49]linear mixed model

Secondary

Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

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 was used to reflect overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. 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 rule. Absolute change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM. Expanded unit of measure is number of skin tape stripping\*grams per square meter per hour.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed 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 Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 15	-229.6 nsts*g/m^2/hour	Standard Deviation 400.8
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 29	-278.0 nsts*g/m^2/hour	Standard Deviation 384.1
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 57	-292.3 nsts*g/m^2/hour	Standard Deviation 409.2
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 85	-284.8 nsts*g/m^2/hour	Standard Deviation 448.7
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Week 16	-321.2 nsts*g/m^2/hour	Standard Deviation 464.2
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 15	230.9 nsts*g/m^2/hour	Standard Deviation 536
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 29	-66.2 nsts*g/m^2/hour	Standard Deviation 299.3
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 57	-22.4 nsts*g/m^2/hour	Standard Deviation 380.9
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 85	59.1 nsts*g/m^2/hour	Standard Deviation 483.9
Atopic Dermatitis Patients	Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Week 16	-27.7 nsts*g/m^2/hour	Standard Deviation 348.1

Secondary

Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 10 STS on LS and 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, 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 Patients	Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Lesional skin	-41.2 grams per square meter per hour	Standard Deviation 20.4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Non-Lesional skin	-0.5 grams per square meter per hour	Standard Deviation 17.9

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 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 evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients arm as pre-specified in the protocol.

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16	-0.8 grams per square meter per hour	Standard Deviation 4

Secondary

Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 15 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Lesional skin	-43.1 grams per square meter per hour	Standard Deviation 20.6
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Non-Lesional skin	-2.0 grams per square meter per hour	Standard Deviation 23.5

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16	-4.5 grams per square meter per hour	Standard Deviation 11.1

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16	-8.0 grams per square meter per hour	Standard Deviation 19.2

Secondary

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

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. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 15	-19.4 grams per square meter per hour	Standard Deviation 21.8
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 57	-29.4 grams per square meter per hour	Standard Deviation 19.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 85	-34.8 grams per square meter per hour	Standard Deviation 21.6
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Week 16	-35.1 grams per square meter per hour	Standard Deviation 17.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 29	-28.3 grams per square meter per hour	Standard Deviation 25.9
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 57	-35.6 grams per square meter per hour	Standard Deviation 23.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 85	-36.2 grams per square meter per hour	Standard Deviation 21.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Week 16	-41.2 grams per square meter per hour	Standard Deviation 20.4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 15	-13.3 grams per square meter per hour	Standard Deviation 23.9
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 29	-27.0 grams per square meter per hour	Standard Deviation 16.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 57	-31.4 grams per square meter per hour	Standard Deviation 22.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Week 16	-43.1 grams per square meter per hour	Standard Deviation 20.6
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 15	-13.6 grams per square meter per hour	Standard Deviation 26.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 85	-32.2 grams per square meter per hour	Standard Deviation 22.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Week 16	-42.6 grams per square meter per hour	Standard Deviation 22.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 15	8.2 grams per square meter per hour	Standard Deviation 22.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 29	-1.0 grams per square meter per hour	Standard Deviation 10.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Week 16	-0.8 grams per square meter per hour	Standard Deviation 13.6
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 15	10.6 grams per square meter per hour	Standard Deviation 29
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 57	-1.8 grams per square meter per hour	Standard Deviation 18.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 85	2.4 grams per square meter per hour	Standard Deviation 24.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 15	17.7 grams per square meter per hour	Standard Deviation 37.6
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 29	-4.8 grams per square meter per hour	Standard Deviation 20.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 85	3.8 grams per square meter per hour	Standard Deviation 31
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Week 16	-2.0 grams per square meter per hour	Standard Deviation 23.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 15	18.6 grams per square meter per hour	Standard Deviation 37.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 29	-7.5 grams per square meter per hour	Standard Deviation 25.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 57	-0.8 grams per square meter per hour	Standard Deviation 27.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 85	5.5 grams per square meter per hour	Standard Deviation 38.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Week 16	-2.1 grams per square meter per hour	Standard Deviation 26.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 29	-27.1 grams per square meter per hour	Standard Deviation 20.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 15	-17.7 grams per square meter per hour	Standard Deviation 24.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 85	-33.7 grams per square meter per hour	Standard Deviation 18.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 29	-25.5 grams per square meter per hour	Standard Deviation 16.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 57	-33.3 grams per square meter per hour	Standard Deviation 23.4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 57	0.2 grams per square meter per hour	Standard Deviation 14.8
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 85	3.4 grams per square meter per hour	Standard Deviation 18.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 29	-2.6 grams per square meter per hour	Standard Deviation 14.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Week 16	-0.5 grams per square meter per hour	Standard Deviation 17.9
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 57	-1.2 grams per square meter per hour	Standard Deviation 25.5

Secondary

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and 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, 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 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 Patients arm as pre-specified in the protocol.

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 85	0.1 grams per square meter per hour	Standard Deviation 3.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Week 16	0.0 grams per square meter per hour	Standard Deviation 2.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 15	1.7 grams per square meter per hour	Standard Deviation 3.8
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 29	0.2 grams per square meter per hour	Standard Deviation 2.9
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 57	1.6 grams per square meter per hour	Standard Deviation 4.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 15	2.1 grams per square meter per hour	Standard Deviation 5.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 29	0.4 grams per square meter per hour	Standard Deviation 4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 57	1.5 grams per square meter per hour	Standard Deviation 5.4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 85	-0.4 grams per square meter per hour	Standard Deviation 4.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Week 16	-0.8 grams per square meter per hour	Standard Deviation 4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 15	3.3 grams per square meter per hour	Standard Deviation 15
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 29	-1.9 grams per square meter per hour	Standard Deviation 8.8
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 57	0.5 grams per square meter per hour	Standard Deviation 12.8
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 85	-3.0 grams per square meter per hour	Standard Deviation 12.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Week 16	-4.5 grams per square meter per hour	Standard Deviation 11.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 15	5.6 grams per square meter per hour	Standard Deviation 22.4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 29	1.9 grams per square meter per hour	Standard Deviation 20.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 57	0.0 grams per square meter per hour	Standard Deviation 19.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 85	-5.2 grams per square meter per hour	Standard Deviation 23.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Week 16	-8.0 grams per square meter per hour	Standard Deviation 19.2

Secondary

Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients 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 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 5 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 evaluable 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 Patients	Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients at Week 16	-35.1 grams per square meter per hour	Standard Deviation 17.1

Secondary

Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients 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 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 evaluable 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 Patients	Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16	-0.8 grams per square meter per hour	Standard Deviation 13.6

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16	0.0 grams per square meter per hour	Standard Deviation 2.7

Secondary

Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and 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. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots 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 rule. Absolute change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM. Expanded unit of measure is number of skin tape stripping\*grams per square meter per hour.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients arm as pre-specified in the protocol.

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 15	49.6 nsts*g/m^2/hour	Standard Deviation 157.9
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 29	-17.7 nsts*g/m^2/hour	Standard Deviation 133.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 57	20.9 nsts*g/m^2/hour	Standard Deviation 145.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 85	-31.2 nsts*g/m^2/hour	Standard Deviation 148.4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Week 16	-46.5 nsts*g/m^2/hour	Standard Deviation 125.5

Secondary

Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

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 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, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.

Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 4	3.9 grams per square meter per hour	Standard Deviation 4.6
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 8	1.4 grams per square meter per hour	Standard Deviation 3.1
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 11	1.2 grams per square meter per hour	Standard Deviation 3.3
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 15	1.5 grams per square meter per hour	Standard Deviation 2.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 22	1.4 grams per square meter per hour	Standard Deviation 2.5
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 29	0.4 grams per square meter per hour	Standard Deviation 2.2
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 43	-0.1 grams per square meter per hour	Standard Deviation 2.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 57	1.6 grams per square meter per hour	Standard Deviation 4
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 85	0.1 grams per square meter per hour	Standard Deviation 2.7
Atopic Dermatitis Patients	Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Week 16	0.4 grams per square meter per hour	Standard Deviation 2.8

Secondary

Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.

Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 4	-3.0 grams per square meter per hour	Standard Deviation 14
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 8	-5.6 grams per square meter per hour	Standard Deviation 18.8
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 11	-8.2 grams per square meter per hour	Standard Deviation 16
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 15	-10.4 grams per square meter per hour	Standard Deviation 16.6
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 22	-19.3 grams per square meter per hour	Standard Deviation 14
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 29	-17.7 grams per square meter per hour	Standard Deviation 14.4
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 43	-20.9 grams per square meter per hour	Standard Deviation 14.9
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 57	-20.9 grams per square meter per hour	Standard Deviation 14
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 85	-22.4 grams per square meter per hour	Standard Deviation 16.7
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Week 16	-24.3 grams per square meter per hour	Standard Deviation 16.3
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 4	2.7 grams per square meter per hour	Standard Deviation 7.6
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 8	3.8 grams per square meter per hour	Standard Deviation 11
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 11	2.1 grams per square meter per hour	Standard Deviation 10.1
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 15	2.6 grams per square meter per hour	Standard Deviation 11.5
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 22	0.4 grams per square meter per hour	Standard Deviation 8.9
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 29	-1.2 grams per square meter per hour	Standard Deviation 11.1
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 43	-1.7 grams per square meter per hour	Standard Deviation 9.4
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 57	-0.9 grams per square meter per hour	Standard Deviation 13
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 85	1.0 grams per square meter per hour	Standard Deviation 15.3
Atopic Dermatitis Patients	Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Week 16	-0.7 grams per square meter per hour	Standard Deviation 12.3

Secondary

Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Lesional skin	-42.6 grams per square meter per hour	Standard Deviation 22.1
Atopic Dermatitis Patients	Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Non-Lesional skin	-2.1 grams per square meter per hour	Standard Deviation 26.2

Secondary

Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and 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. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. 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 rule. Percent change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 57	-24.3 percent change	Standard Deviation 49.2
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 15	-17.0 percent change	Standard Deviation 37.5
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 29	-20.5 percent change	Standard Deviation 39.3
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Day 85	-24.5 percent change	Standard Deviation 56.9
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: Week 16	-29.2 percent change	Standard Deviation 43.5
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 15	52.4 percent change	Standard Deviation 99.9
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 29	1.0 percent change	Standard Deviation 48.8
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 57	17.7 percent change	Standard Deviation 89.4
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Day 85	29.5 percent change	Standard Deviation 105.6
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: Week 16	19.4 percent change	Standard Deviation 97.6

Secondary

Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and 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. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots 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 rule. Percent Change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 15	23.3 percent change	Standard Deviation 51.2
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 29	2.6 percent change	Standard Deviation 39.6
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 57	14.0 percent change	Standard Deviation 36.2
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Day 85	1.0 percent change	Standard Deviation 45.6
Atopic Dermatitis Patients	Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	Week 16	-5.5 percent change	Standard Deviation 30.5

Secondary

Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 10 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Lesional skin	-54.9 percent change	Standard Deviation 17.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Non-Lesional skin	26.2 percent change	Standard Deviation 111.8

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16	-2.0 percent change	Standard Deviation 23.5

Secondary

Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 and non-LS (first spot) in AD participants were reported in this OM.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Lesional skin	-51.2 percent change	Standard Deviation 17.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16	Non-Lesional skin	25.1 percent change	Standard Deviation 116.5

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16	-7.2 percent change	Standard Deviation 35.8

Secondary

Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients 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 and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 20 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16	Lesional skin	-47.7 percent change	Standard Deviation 20.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16	Non-Lesional skin	16.6 percent change	Standard Deviation 91.5

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16	-5.8 percent change	Standard Deviation 46

Secondary

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

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. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 15	-14.5 percent change	Standard Deviation 24.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 29	-33.0 percent change	Standard Deviation 17.7
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Week 16	-47.7 percent change	Standard Deviation 20.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 57	22.8 percent change	Standard Deviation 89
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 85	33.7 percent change	Standard Deviation 106.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Week 16	17.6 percent change	Standard Deviation 82.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 15	55.1 percent change	Standard Deviation 109.3
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Week 16	26.2 percent change	Standard Deviation 111.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 57	23.5 percent change	Standard Deviation 104.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 15	53.1 percent change	Standard Deviation 96
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 29	-3.8 percent change	Standard Deviation 53.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 85	30.4 percent change	Standard Deviation 104.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Week 16	16.6 percent change	Standard Deviation 91.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 15	-25.1 percent change	Standard Deviation 34
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 29	-38.9 percent change	Standard Deviation 23.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 57	-45.6 percent change	Standard Deviation 23.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Day 85	-50.6 percent change	Standard Deviation 26.7
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 5 STS: Week 16	-54.6 percent change	Standard Deviation 18
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 15	-18.5 percent change	Standard Deviation 30.7
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 29	-32.5 percent change	Standard Deviation 29.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 57	-46.7 percent change	Standard Deviation 22.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Day 85	-47.0 percent change	Standard Deviation 25.6
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 10 STS: Week 16	-54.9 percent change	Standard Deviation 17.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 57	-39.1 percent change	Standard Deviation 22.3
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Day 85	-43.4 percent change	Standard Deviation 24.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 15 STS: Week 16	-51.2 percent change	Standard Deviation 17.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 15	-11.6 percent change	Standard Deviation 27.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 29	-29.1 percent change	Standard Deviation 18.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 57	-37.4 percent change	Standard Deviation 22.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Lesional skin: After 20 STS: Day 85	-38.8 percent change	Standard Deviation 28.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 15	49.8 percent change	Standard Deviation 100
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 5 STS: Day 29	8.0 percent change	Standard Deviation 46.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 29	4.5 percent change	Standard Deviation 52.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 57	18.6 percent change	Standard Deviation 91
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 10 STS: Day 85	31.0 percent change	Standard Deviation 116.3
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 15	70.9 percent change	Standard Deviation 128.3
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 29	2.4 percent change	Standard Deviation 58.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Day 85	34.7 percent change	Standard Deviation 112
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 15 STS: Week 16	25.1 percent change	Standard Deviation 116.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16	Non-Lesional skin: After 20 STS: Day 57	14.3 percent change	Standard Deviation 80.7

Secondary

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and 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, 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 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.

Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 15	15.9 percent change	Standard Deviation 27.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 29	5.2 percent change	Standard Deviation 24.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 57	16.0 percent change	Standard Deviation 27.6
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Day 85	5.8 percent change	Standard Deviation 26.3
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 5 STS: Week 16	1.2 percent change	Standard Deviation 21.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 29	6.8 percent change	Standard Deviation 27.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 57	13.7 percent change	Standard Deviation 25.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Week 16	-2.0 percent change	Standard Deviation 23.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 15	17.6 percent change	Standard Deviation 31.3
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 10 STS: Day 85	3.1 percent change	Standard Deviation 26.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 15	32.3 percent change	Standard Deviation 80.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 29	1.6 percent change	Standard Deviation 37.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 57	15.3 percent change	Standard Deviation 49.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Day 85	1.7 percent change	Standard Deviation 60.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 15 STS: Week 16	-7.2 percent change	Standard Deviation 35.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 15	44.2 percent change	Standard Deviation 107.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 29	31.1 percent change	Standard Deviation 94.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 57	22.0 percent change	Standard Deviation 63.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Day 85	8.5 percent change	Standard Deviation 89.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16	After 20 STS: Week 16	-5.8 percent change	Standard Deviation 46

Secondary

Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients 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 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 evaluable 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 Patients	Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16	17.6 percent change	Standard Deviation 82.2

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 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

Arm	Measure	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16	1.2 percent change	Standard Deviation 21.9

Secondary

Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.

Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 29	6.4 percent change	Standard Deviation 47
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 4	-0.7 percent change	Standard Deviation 30.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 8	-5.3 percent change	Standard Deviation 42.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 11	-12.9 percent change	Standard Deviation 32.6
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 15	-16.3 percent change	Standard Deviation 34.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 22	-37.8 percent change	Standard Deviation 20.6
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 29	-35.1 percent change	Standard Deviation 19.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 43	-40.6 percent change	Standard Deviation 21.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 57	-42.1 percent change	Standard Deviation 20.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Day 85	-42.7 percent change	Standard Deviation 23.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Lesional skin: Week 16	-48.7 percent change	Standard Deviation 22.6
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 4	25.2 percent change	Standard Deviation 40.6
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 8	27.9 percent change	Standard Deviation 59.5
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 11	20.1 percent change	Standard Deviation 46.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 15	24.0 percent change	Standard Deviation 56.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 22	14.5 percent change	Standard Deviation 47.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 43	5.6 percent change	Standard Deviation 57.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 57	17.8 percent change	Standard Deviation 85.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Day 85	27.5 percent change	Standard Deviation 99.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Non-Lesional skin: Week 16	18.8 percent change	Standard Deviation 85.2

Secondary

Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

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 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, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.

Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 4	42.6 percent change	Standard Deviation 44.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 8	20.5 percent change	Standard Deviation 38.4
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 11	15.9 percent change	Standard Deviation 31
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 15	16.6 percent change	Standard Deviation 25.1
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 22	18.5 percent change	Standard Deviation 32.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 29	8.0 percent change	Standard Deviation 20.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 43	4.0 percent change	Standard Deviation 26.2
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 57	20.3 percent change	Standard Deviation 31.9
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Day 85	6.0 percent change	Standard Deviation 21.8
Atopic Dermatitis Patients	Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16	Week 16	4.3 percent change	Standard Deviation 25.3

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026

Dupilumab Skin Barrier Function Study in Atopic Dermatitis

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16

Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients at Week 16

Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16

Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16

Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16

Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16