Phase 3
N=406
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT05032859 ↗Enrolled (actual)
406
Serious AEs
0.5%
Results posted
Sep 2025
Primary outcome: Primary: Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. — 46.4; 18.0 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tapinarof cream, 1% (Drug); vehicle cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. |
46.4; 18.0 | <0.0001 sig |
| SECONDARY Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. |
59.1; 21.2 | <0.0001 sig |
| SECONDARY Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8. |
-10.36; -3.14 | <0.0001 sig |
| SECONDARY Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. |
30.1; 10.0 | 0.0013 sig |
| SECONDARY Percent of Subjects ≥ 12 Years Old With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the Average Weekly PP-NRS From Baseline to Week 8. |
52.8; 24.1 | 0.0015 sig |
Summary
This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects ages 2 and above with clinical diagnosis of AD
- Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
- A vIGA-AD score of ≥3 at screening and baseline
- An EASI score of ≥6 at screening and baseline
- Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
- Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
- Must not be pregnant
- Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
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 (NCT05032859). 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.