Atopic Dermatitis
Conditions
Keywords
Pediatric Atopic Dermatitis, Eczema, tapinarof, topical
Brief summary
The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.
Interventions
Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
DRUGVehicle Cream
Applied topically once daily to lesions on participant's skin during the Double-Blind period.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo). Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.
Eligibility
Sex/Gender
ALL
Age
3 Months to 23 Months
Healthy volunteers
No
Inclusion criteria
* Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \<24 months of age at the Screening visit. * Clinical diagnosis of atopic dermatitis (AD), AD covering \>5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4 * Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities * Legal guardian or primary caregiver is able and willing to adhere to protocol requirements
Exclusion criteria
* Significant neurological disorder or history of seizure * Know clinically significant cardiac rhythm or cardiac disorder * History of sudden infant death in a sibling * Clinically significant chromosome abnormality * History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation * Diseases that could cause pruritic and/or sleep disruption * Immunocompromised * Current chronic or acute infection requiring treatment * Use of prohibited medication(s) or procedure(s) * Use of prohibited medications by breastfeeding mother if breastfeeding participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8 | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. | The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. |
| Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period | Baseline to the end of the Open-Label Period, up to 56 weeks. | The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint.. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. | The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease. |
| Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8 | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. | Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease. |
| Number of participants with one or more Treatment Emergent Adverse Events (TEAEs) | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks | TEAEs are AEs that started on or after the first dose of study medication. |
| Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs) | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks . | TEAEs are AEs that started on or after the first dose of study medication. |
| Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks | The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation. |
| Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas) | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks | The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation. |
| Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8 | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. | Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \[10 handprints\], upper extremities = 20% \[20 handprints\], trunk (including axillae and groin) = 30% \[30 handprints\], lower extremities, including buttocks, = 40% \[40 handprints\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall. |
Countries
Canada, United States
Contacts
STUDY_DIRECTORClinical Lead Late-Stage Clinical Development
Organon and Co
Outcome results
None listed