Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

NCT05014568 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DMVT-505-3101
• Study Type: interventional
• Target: 407
• Locations: 2 countries
• Sites: 67

Brief 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.

Conditions

Atopic Dermatitis

Keywords

eczema; pediatric; tapinarof; phase 3; topical

Outcome Measures

Primary Outcomes (1)

• 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.

  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 calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. Statistics are based on 100 imputed datasets.

  Baseline to Week 8

Secondary Outcomes (4)

• Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.

  Baseline to Week 8

• Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.

  Baseline to Week 8

• Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.

  Baseline to Week 8

• 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.

  Baseline to Week 8

Study Arms (2)

tapinarof cream

EXPERIMENTAL

tapinarof cream, 1%, applied topically once daily

Drug: tapinarof cream, 1%

vehicle cream

PLACEBO COMPARATOR

vehicle cream, applied topically once daily

Drug: Vehicle cream

Interventions

tapinarof cream, 1% DRUG

applied topically once daily

tapinarof cream

Vehicle cream DRUG

applied topically once daily

vehicle cream

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (67)

Dermavant Investigative Site

Birmingham, Alabama, 35244, United States

Location

Dermavant Investigative Site

Phoenix, Arizona, 85032, United States

Location

Dermavant Investigative Site

Bryant, Arkansas, 72022, United States

Location

Dermavant Investigative Site

Beverly Hills, California, 90212, United States

Location

Dermavant Investigative Site

Fountain Valley, California, 92708, United States

Location

Dermavant Investigative Site

Fremont, California, 94538, United States

Location

Dermavant Investigative Site

Inglewood, California, 90301, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90017, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90033, United States

Location

Dermavant Investigative Site

Mission Viejo, California, 92691, United States

Location

Dermavant Investigative Site

Sacramento, California, 95815, United States

Location

Dermavant Investigative Site

Washington D.C., District of Columbia, 20037, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33431, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33486, United States

Location

Dermavant Investigative Site

Brandon, Florida, 33511, United States

Location

Dermavant Investigative Site

Coral Gables, Florida, 33146, United States

Location

Dermavant Investigative Site

Jacksonville, Florida, 32256, United States

Location

Dermavant Investigative Site

Margate, Florida, 33063, United States

Location

Dermavant Investigative Site

Miami, Florida, 33126, United States

Location

Dermavant Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Dermavant Investigative Site

Orlando, Florida, 32801, United States

Location

Dermavant Investigative Site

Pinellas Park, Florida, 33781, United States

Location

Dermavant Investigative Site

Sweetwater, Florida, 33172, United States

Location

Dermavant Investigative Site

Tampa, Florida, 33615, United States

Location

Dermavant Investigative Site

Marietta, Georgia, 30060, United States

Location

Dermavant Investigative Site

Sandy Springs, Georgia, 30328, United States

Location

Dermavant Investigative Site

Savannah, Georgia, 31406, United States

Location

Dermavant Investigative Site

Plainfield, Indiana, 46168, United States

Location

Dermavant Investigative Site

Louisville, Kentucky, 40217, United States

Location

Dermavant Investigative Site

Owensboro, Kentucky, 42301, United States

Location

Dermavant Investigative Site

Covington, Louisiana, 70433, United States

Location

Dermavant Investigative Site

Monroe, Louisiana, 71201, United States

Location

Dermavant Investigative Site

Largo, Maryland, 20774, United States

Location

Dermavant Investigative Site

Bay City, Michigan, 48706, United States

Location

Dermavant Investigative Site

Clarkston, Michigan, 48346, United States

Location

Dermavant Investigative Site

Warren, Michigan, 48088, United States

Location

Dermavant Investigative Site

Ypsilanti, Michigan, 48197, United States

Location

Dermavant Investigative Site

New Brighton, Minnesota, 55112, United States

Location

Dermavant Investigative Site

Missoula, Montana, 59808, United States

Location

Dermavant Investigative Site

Omaha, Nebraska, 68144, United States

Location

Dermavant Investigative Site

Garden City, New York, 11530, United States

Location

Dermavant Investigative Site

New York, New York, 10075, United States

Location

Dermavant Investigative Site

Bexley, Ohio, 43209, United States

Location

Dermavant Investigative Site

Cleveland, Ohio, 44106, United States

Location

Dermavant Investigative Site

Oklahoma City, Oklahoma, 73071, United States

Location

Dermavant Investigative Site

Oklahoma City, Oklahoma, 73120, United States

Location

Dermavant Investigative Site

Gresham, Oregon, 97030, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97223, United States

Location

Dermavant Investigative Site

Hershey, Pennsylvania, 17033, United States

Location

Dermavant Investigative Site

Greenville, South Carolina, 29615, United States

Location

Dermavant Investigative Site

Knoxville, Tennessee, 37909, United States

Location

Dermavant Investigative Site

Austin, Texas, 78745, United States

Location

Dermavant Investigative Site

Bellaire, Texas, 77401, United States

Location

Dermavant Investigative Site

Cypress, Texas, 77433, United States

Location

Dermavant Investigative Site

Dallas, Texas, 75230, United States

Location

Dermavant Investigative Site

Houston, Texas, 77098, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78218, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78229, United States

Location

Dermavant Investigative Site

Sugar Land, Texas, 77479, United States

Location

Dermavant Investigative Site

Richmond, Virginia, 23226, United States

Location

Dermavant Investigative Site

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dermavant Investigative Site

Burlington, Ontario, L7L 6W6, Canada

Location

Dermavant Investigative Site

Cobourg, Ontario, K9A 0Z4, Canada

Location

Dermavant Investigative Site

Hamilton, Ontario, L8S 1G5, Canada

Location

Dermavant Investigative Site

Oakville, Ontario, L6J 7W5, Canada

Location

Dermavant Investigative Site

Ottawa, Ontario, K2C 3N2, Canada

Location

Dermavant Investigative Site

Montreal, Quebec, H2X 2V1, Canada

Location

Related Publications (5)

• Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.

  PMID: 38777187 RESULT

• Alexis AF, Kircik L, Chovatiya R, Rice ZP, Soong W, Bhutani T, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM, Armstrong AW. Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials. Dermatol Ther (Heidelb). 2025 Sep;15(9):2667-2682. doi: 10.1007/s13555-025-01489-w. Epub 2025 Jul 22.

  PMID: 40696240 DERIVED

• Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.

  PMID: 40600584 DERIVED

• Gold LS, Del Rosso J, Ehst BD, Zirwas MJ, Green LJ, Brown PM, Rubenstein DS, Piscitelli SC, Tallman AM. Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials. J Dermatolog Treat. 2025 Dec;36(1):2444489. doi: 10.1080/09546634.2024.2444489. Epub 2025 Jan 12.

  PMID: 39799945 DERIVED

• Simpson EL, Hebert AA, Browning J, Serrao RT, Sofen H, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM. Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children. Dermatol Ther (Heidelb). 2025 Jan;15(1):111-124. doi: 10.1007/s13555-024-01318-6. Epub 2025 Jan 7.

  PMID: 39777610 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon and Co

pdrl@organon.com

551-430-6000

Study Officials

• Diana Villalobos

  Dermavant Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, study center staff, subject, and sponsor will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: April 7, 2023
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (60); CA (7)