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Atopic DermatitisPhase 3NCT05032859

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

A Phase 3 study testing tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
406 participants
Where
62 sitesin 2 countries
Study dates
23 Sep 2021to 8 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

62 sites in 2 countries.

62 sites in 2 countries

United States57 sites

  • Dermavant Investigative Site

    Anderson, South Carolina, 29621

  • Dermavant Investigative Site

    Baton Rouge, Louisiana, 70808

  • Dermavant Investigative Site

    Baton Rouge, Louisiana, 70809

  • Dermavant Investigative Site

    Bellaire, Texas, 77401

  • Dermavant Investigative Site

    Birmingham, Alabama, 35244

  • Dermavant Investigative Site

    Boca Raton, Florida, 33428

  • Dermanvant Investigative Site

    Brooklyn, New York, 11203

  • Dermavant Investigative Site

    Cerritos, California, 90702

  • Dermavant Investigative Site

    Charlotte, North Carolina, 28277

  • Dermavant Investigative Site

    Dayton, Ohio, 45414

  • Dermavant Investigative Site

    Delray Beach, Florida, 33484

  • Dermavant Investigative Site

    Detroit, Michigan, 48202

  • Dermavant Investigative Site

    Dripping Springs, Texas, 78620

  • Dermavant Investigative Site

    East Greenwich, Rhode Island, 02818

  • Dermavant Investigative Site

    East Windsor, New Jersey, 08520

  • Dermavant Investigative Site

    Evansville, Indiana, 47715

  • Dermavant Investigative Site

    Fort Smith, Arkansas, 72916

  • Dermavant Investigative Site

    Grapevine, Texas, 76051

  • Dermavant Investigative Site

    Houston, Texas, 77004

  • Dermavant Investigative Site

    Houston, Texas, 77061

  • Dermavant Investigative Site

    Huntington Beach, California, 92647

  • Dermavant Investigative Site

    Jacksonville, Florida, 32256

  • Dermavant Investigative Site

    Lancaster, California, 93534

  • Dermavant Investigative Site

    Las Vegas, Nevada, 89148

  • Dermavant Investigative Site

    Lexington, Kentucky, 40517

  • Dermavant Investigative Site

    Lincoln, Nebraska, 68516

  • Dermavant Investigative Site

    Long Beach, California, 90806

  • Dermavant Investigative Site

    Los Angeles, California, 90045

  • Dermavant Investigative Site

    Louisville, Kentucky, 40241

  • Dermavant Investigative Site

    Mason, Ohio, 45040

  • Dermavant Investigative Site

    Mayfield Heights, Ohio, 44124

  • Dermavant Investigative Site

    Medford, Oregon, 97504

  • Dermavant Investigative Site

    Memphis, Tennessee, 38119

  • Dermavant Investigative Site

    Miami, Florida, 33165

  • Dermavant Investigative Site

    Miami, Florida, 33173

  • Dermavant Investigative Site

    Miami Lakes, Florida, 33014

  • Dermavant Investigative Site

    New Orleans, Louisiana, 70115

  • Dermavant Investigative Site

    North Charleston, South Carolina, 29420

  • Dermavant Investigative Site

    Omaha, Nebraska, 68114

  • Dermavant Investigative Site

    Overland Park, Kansas, 66210

  • Dermavant Investigative Site

    Portland, Oregon, 97210

  • Dermavant Investigative Site

    Portland, Oregon, 97239

  • Dermavant Investigative Site

    Rockville, Maryland, 20850

  • Dermavant Investigative Site

    San Antonio, Texas, 78213

  • Dermavant Investigative Site

    San Diego, California, 92123

  • Dermavant Investigative Site

    San Francisco, California, 94115

  • Dermavant Investigative Site

    Santa Ana, California, 92701

  • Dermavant Investigative Site

    Santa Monica, California, 90404

  • Dermavant Investigative Site

    Scottsdale, Arizona, 85255

  • Dermavant Investigative Site

    Scottsdale, Arizona, 85260

  • Dermavant Investigative Site

    Snellville, Georgia, 30078

  • Dermavant Investigative Site

    Spartanburg, South Carolina, 29303

  • Dermavant Investigative Site

    Spokane, Washington, 99202

  • Dermavant Investigative Site

    Tampa, Florida, 33607

  • Dermavant Investigative Site

    Tulsa, Oklahoma, 74114

  • Dermavant Investigative Site

    Watertown, New York, 13601

  • Dermavant Investigative Site

    Webster, Texas, 77598

Other trials in United States

Canada5 sites

  • Dermavant Investigative Site

    Barrie, Ontario, L4M 7G1

  • Dermavant Investigative Site

    Markham, Ontario, L3P 1X3

  • Dermavant Investigative Site

    Surrey, British Columbia, V3R 6A7

  • Dermavant Investigative Site

    Waterloo, Ontario, N2J 1C4

  • Dermavant Investigative Site

    Windsor, Ontario, N8W 1E6

Other trials in Canada

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.

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 groups in NCT05032859
Study groupRoleWhat they receive
tapinarof creamExperimentaltapinarof cream, 1%, applied topically once daily
Receives: Drug: tapinarof cream, 1%
vehicle creamPlacebo comparatorvehicle 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.

  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.

    Measured: Baseline to Week 8

Secondary outcomes (4)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted2 Sep 2021
  2. Study start23 Sep 2021
  3. Primary completion3 Feb 2023
  4. Study completion8 Feb 2023

Resources

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
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032859
Sponsor's protocol ID
DMVT-505-3102
Status last verified
Aug 2025
First submitted
27 Aug 2021
Last updated
2 Sep 2025
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 38777187

  • 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.

    PubMed 40696240

  • 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.

    PubMed 40600584

  • Bissonnette 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 40383273

  • 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.

    PubMed 39799945

  • 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.

    PubMed 39777610

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 62 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032859, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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