Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
NCT ID: NCT05014568
Last Updated: 2025-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
407 participants
INTERVENTIONAL
2021-09-01
2023-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tapinarof cream
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%
applied topically once daily
vehicle cream
vehicle cream, applied topically once daily
Vehicle cream
applied topically once daily
Interventions
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tapinarof cream, 1%
applied topically once daily
Vehicle cream
applied topically once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
2 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Villalobos
Role: STUDY_DIRECTOR
Dermavant Sciences, Inc.
Locations
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Dermavant Investigative Site
Birmingham, Alabama, United States
Dermavant Investigative Site
Phoenix, Arizona, United States
Dermavant Investigative Site
Bryant, Arkansas, United States
Dermavant Investigative Site
Beverly Hills, California, United States
Dermavant Investigative Site
Fountain Valley, California, United States
Dermavant Investigative Site
Fremont, California, United States
Dermavant Investigative Site
Inglewood, California, United States
Dermavant Investigative Site
Los Angeles, California, United States
Dermavant Investigative Site
Los Angeles, California, United States
Dermavant Investigative Site
Mission Viejo, California, United States
Dermavant Investigative Site
Sacramento, California, United States
Dermavant Investigative Site
Washington D.C., District of Columbia, United States
Dermavant Investigative Site
Boca Raton, Florida, United States
Dermavant Investigative Site
Boca Raton, Florida, United States
Dermavant Investigative Site
Brandon, Florida, United States
Dermavant Investigative Site
Coral Gables, Florida, United States
Dermavant Investigative Site
Jacksonville, Florida, United States
Dermavant Investigative Site
Margate, Florida, United States
Dermavant Investigative Site
Miami, Florida, United States
Dermavant Investigative Site
Miami Lakes, Florida, United States
Dermavant Investigative Site
Orlando, Florida, United States
Dermavant Investigative Site
Pinellas Park, Florida, United States
Dermavant Investigative Site
Sweetwater, Florida, United States
Dermavant Investigative Site
Tampa, Florida, United States
Dermavant Investigative Site
Marietta, Georgia, United States
Dermavant Investigative Site
Sandy Springs, Georgia, United States
Dermavant Investigative Site
Savannah, Georgia, United States
Dermavant Investigative Site
Plainfield, Indiana, United States
Dermavant Investigative Site
Louisville, Kentucky, United States
Dermavant Investigative Site
Owensboro, Kentucky, United States
Dermavant Investigative Site
Covington, Louisiana, United States
Dermavant Investigative Site
Monroe, Louisiana, United States
Dermavant Investigative Site
Largo, Maryland, United States
Dermavant Investigative Site
Bay City, Michigan, United States
Dermavant Investigative Site
Clarkston, Michigan, United States
Dermavant Investigative Site
Warren, Michigan, United States
Dermavant Investigative Site
Ypsilanti, Michigan, United States
Dermavant Investigative Site
New Brighton, Minnesota, United States
Dermavant Investigative Site
Missoula, Montana, United States
Dermavant Investigative Site
Omaha, Nebraska, United States
Dermavant Investigative Site
Garden City, New York, United States
Dermavant Investigative Site
New York, New York, United States
Dermavant Investigative Site
Bexley, Ohio, United States
Dermavant Investigative Site
Cleveland, Ohio, United States
Dermavant Investigative Site
Oklahoma City, Oklahoma, United States
Dermavant Investigative Site
Oklahoma City, Oklahoma, United States
Dermavant Investigative Site
Gresham, Oregon, United States
Dermavant Investigative Site
Portland, Oregon, United States
Dermavant Investigative Site
Hershey, Pennsylvania, United States
Dermavant Investigative Site
Greenville, South Carolina, United States
Dermavant Investigative Site
Knoxville, Tennessee, United States
Dermavant Investigative Site
Austin, Texas, United States
Dermavant Investigative Site
Bellaire, Texas, United States
Dermavant Investigative Site
Cypress, Texas, United States
Dermavant Investigative Site
Dallas, Texas, United States
Dermavant Investigative Site
Houston, Texas, United States
Dermavant Investigative Site
San Antonio, Texas, United States
Dermavant Investigative Site
San Antonio, Texas, United States
Dermavant Investigative Site
Sugar Land, Texas, United States
Dermavant Investigative Site
Richmond, Virginia, United States
Dermavant Investigative Site
Winnipeg, Manitoba, Canada
Dermavant Investigative Site
Burlington, Ontario, Canada
Dermavant Investigative Site
Cobourg, Ontario, Canada
Dermavant Investigative Site
Hamilton, Ontario, Canada
Dermavant Investigative Site
Oakville, Ontario, Canada
Dermavant Investigative Site
Ottawa, Ontario, Canada
Dermavant Investigative Site
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DMVT-505-3101
Identifier Type: -
Identifier Source: org_study_id
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