Atopic DermatitisPhase 3NCT05014568
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
A Phase 3 study testing tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 67 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- tapinarof cream, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 67 sitesin 2 countries
- Study dates
- 1 Sep 2021to 7 Apr 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
United States60 sites
Dermavant Investigative Site
Austin, Texas, 78745
Dermavant Investigative Site
Bay City, Michigan, 48706
Dermavant Investigative Site
Bellaire, Texas, 77401
Dermavant Investigative Site
Beverly Hills, California, 90212
Dermavant Investigative Site
Bexley, Ohio, 43209
Dermavant Investigative Site
Birmingham, Alabama, 35244
Dermavant Investigative Site
Boca Raton, Florida, 33431
Dermavant Investigative Site
Boca Raton, Florida, 33486
Dermavant Investigative Site
Brandon, Florida, 33511
Dermavant Investigative Site
Bryant, Arkansas, 72022
Dermavant Investigative Site
Clarkston, Michigan, 48346
Dermavant Investigative Site
Cleveland, Ohio, 44106
Dermavant Investigative Site
Coral Gables, Florida, 33146
Dermavant Investigative Site
Covington, Louisiana, 70433
Dermavant Investigative Site
Cypress, Texas, 77433
Dermavant Investigative Site
Dallas, Texas, 75230
Dermavant Investigative Site
Fountain Valley, California, 92708
Dermavant Investigative Site
Fremont, California, 94538
Dermavant Investigative Site
Garden City, New York, 11530
Dermavant Investigative Site
Greenville, South Carolina, 29615
Dermavant Investigative Site
Gresham, Oregon, 97030
Dermavant Investigative Site
Hershey, Pennsylvania, 17033
Dermavant Investigative Site
Houston, Texas, 77098
Dermavant Investigative Site
Inglewood, California, 90301
Dermavant Investigative Site
Jacksonville, Florida, 32256
Dermavant Investigative Site
Knoxville, Tennessee, 37909
Dermavant Investigative Site
Largo, Maryland, 20774
Dermavant Investigative Site
Los Angeles, California, 90017
Dermavant Investigative Site
Los Angeles, California, 90033
Dermavant Investigative Site
Louisville, Kentucky, 40217
Dermavant Investigative Site
Margate, Florida, 33063
Dermavant Investigative Site
Marietta, Georgia, 30060
Dermavant Investigative Site
Miami, Florida, 33126
Dermavant Investigative Site
Miami Lakes, Florida, 33014
Dermavant Investigative Site
Mission Viejo, California, 92691
Dermavant Investigative Site
Missoula, Montana, 59808
Dermavant Investigative Site
Monroe, Louisiana, 71201
Dermavant Investigative Site
New Brighton, Minnesota, 55112
Dermavant Investigative Site
New York, New York, 10075
Dermavant Investigative Site
Oklahoma City, Oklahoma, 73071
Dermavant Investigative Site
Oklahoma City, Oklahoma, 73120
Dermavant Investigative Site
Omaha, Nebraska, 68144
Dermavant Investigative Site
Orlando, Florida, 32801
Dermavant Investigative Site
Owensboro, Kentucky, 42301
Dermavant Investigative Site
Phoenix, Arizona, 85032
Dermavant Investigative Site
Pinellas Park, Florida, 33781
Dermavant Investigative Site
Plainfield, Indiana, 46168
Dermavant Investigative Site
Portland, Oregon, 97223
Dermavant Investigative Site
Richmond, Virginia, 23226
Dermavant Investigative Site
Sacramento, California, 95815
Dermavant Investigative Site
San Antonio, Texas, 78218
Dermavant Investigative Site
San Antonio, Texas, 78229
Dermavant Investigative Site
Sandy Springs, Georgia, 30328
Dermavant Investigative Site
Savannah, Georgia, 31406
Dermavant Investigative Site
Sugar Land, Texas, 77479
Dermavant Investigative Site
Sweetwater, Florida, 33172
Dermavant Investigative Site
Tampa, Florida, 33615
Dermavant Investigative Site
Warren, Michigan, 48088
Dermavant Investigative Site
Washington D.C., District of Columbia, 20037
Dermavant Investigative Site
Ypsilanti, Michigan, 48197
Canada7 sites
Dermavant Investigative Site
Burlington, Ontario, L7L 6W6
Dermavant Investigative Site
Cobourg, Ontario, K9A 0Z4
Dermavant Investigative Site
Hamilton, Ontario, L8S 1G5
Dermavant Investigative Site
Montreal, Quebec, H2X 2V1
Dermavant Investigative Site
Oakville, Ontario, L6J 7W5
Dermavant Investigative Site
Ottawa, Ontario, K2C 3N2
Dermavant Investigative Site
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults
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.
Read the detailed description
This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.
- Conditions
- Atopic Dermatitis
- Being tested
- tapinarof cream, 1%, Vehicle cream
- Keywords
- eczema, pediatric, tapinarof, phase 3, topical
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tapinarof cream, 1%Drug
applied topically once daily
Vehicle creamDrug
applied topically once daily
| Study group | Role | What they receive |
|---|---|---|
| tapinarof cream | Experimental | tapinarof cream, 1%, applied topically once daily Receives: Drug: tapinarof cream, 1% |
| vehicle cream | Placebo comparator | vehicle cream, applied topically once daily Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The Eczema Area and Severity Index (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.
Statistics are based on 100 imputed datasets.
Measured: Baseline to Week 8
Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.
Assessment of percent body surface area (%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.
Measured: 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.
The Eczema Area and Severity Index (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.
Statistics are based on 100 imputed datasets.
Measured: 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.
The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.
Statistics are based on 100 imputed datasets.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Mar 2023
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Villalobos, Study director, Dermavant Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014568
- Sponsor's protocol ID
- DMVT-505-3101
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2021
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38777187Alexis 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.
PubMed 40696240Gold 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.
PubMed 40600584Bissonnette R, Stein Gold L, Kircik L, Simpson EL, Eichenfield LF, Browning J, Hebert AA, Alexis AF, Soong W, Piscitelli SC, Tallman AM, Rubenstein DS, Brown PM, Silverberg JI. Skin clearance, duration of treatment-free interval, and safety of tapinarof cream 1% once daily: Results from ADORING 3, a 48-week phase 3 open-label extension trial in adults and children down to 2 years of age with atopic dermatitis. J Am Acad Dermatol. 2025 Sep;93(3):707-714. doi: 10.1016/j.jaad.2025.05.1391. Epub 2025 May 16.
PubMed 40383273Gold 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.
PubMed 39799945Simpson 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.
PubMed 39777610