Phase 2
N=36
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT05186805 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) — 8; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tapinarof cream, 1% (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) |
8; 0 | — |
| PRIMARY Change From Baseline in Laboratory Values (U/L) |
1.9; 0.7; 0.6 | — |
| PRIMARY Change From Baseline in Laboratory Values (g/L) |
-0.7; -0.5; -1.7; 0.0 | — |
| PRIMARY Change From Baseline in Laboratory Values (mmol/L) |
-0.3; -0.006; 0.0; 0.20; 0.08; 0.1 | — |
| PRIMARY Change From Baseline in Laboratory Values (Umol/L) |
-0.34; -0.9; -6.0 | — |
| PRIMARY Change From Baseline in Laboratory Values (10^9 Cells/L) |
0.01; 0.00; 0.71; 0.38; -0.06; 0.36 | — |
| PRIMARY Change From Baseline in Laboratory Values (%) |
0.05; -0.13; 0.81; -0.81; 0.08; 0.06 | — |
| PRIMARY Change From Baseline in Laboratory Values (pg) |
0.26 | — |
| PRIMARY Change From Baseline in Laboratory Values (fL) |
1.26 | — |
| PRIMARY Change From Baseline in Laboratory Values (10^12 Cells/L) |
-0.055 | — |
| PRIMARY Change From Baseline in Laboratory Values (L/L) |
0.002 | — |
| PRIMARY Mean Change in Local Tolerability Scale (LTS) |
0.2; 0.1 | — |
| PRIMARY Tapinarof Plasma PK Parameters on Day 1: AUC0-τ |
4690 | — |
| PRIMARY Tapinarof Plasma PK Parameters on Day 1: Cmax |
2440 | — |
| PRIMARY Tapinarof Plasma PK Parameters on Day 1: Tmax |
2.37 | — |
| PRIMARY Tapinarof Plasma Concentration: Cτ |
1330 | — |
| PRIMARY Change From Baseline in Vital Signs (Beats/Min) |
0.9 | — |
| PRIMARY Change From Baseline in Vital Signs (mmHg) |
1.1; -0.9 | — |
| PRIMARY Change From Baseline in Vital Signs (C) |
-0.08 | — |
| SECONDARY Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) |
0; 0; 0; 0; 8; 14 | — |
| SECONDARY Number of Subjects Who Have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Score of Almost Clear (0 or 1) and at Least a 2-grade Reduction From Baseline |
8 | — |
| SECONDARY Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score |
20 | — |
| SECONDARY Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score |
7 | — |
| SECONDARY Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score |
4 | — |
| SECONDARY Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28 |
-12.16 | — |
| SECONDARY Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28 |
-53.38 | — |
| SECONDARY Mean Change in Percent of Total Body Surface Area (%BSA) Affected |
-21.06 | — |
| SECONDARY Percent Change in Percent of Total Body Surface Area (%BSA) Affected |
-49.40 | — |
| SECONDARY Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values |
-85.15 | — |
| SECONDARY Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values |
-62.77 | — |
| SECONDARY Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score |
-4.155 | — |
| SECONDARY Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score |
14; 18 | — |
Summary
This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old
- BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.
- vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)
- Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- Capable of giving written informed consent
- Negative pregnancy test at Baseline (Day 1)
Exclusion Criteria
- Immunocompromised at screening
- Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
- Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
- Screening total bilirubin > 1.5x ULN
- Current or chronic history of liver disease
- Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Subjects who would not be considered suitable for topical therapy
- Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
- History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
- Pregnant or lactating females
- History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
- Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Data sourced from ClinicalTrials.gov (NCT05186805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.