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New eczema cream shows promise in major trial

NCT ID NCT05014568

Symptom relief Sponsor: Organon and Co Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a cream called tapinarof on 407 people aged 2 and older with moderate to severe eczema (atopic dermatitis). Participants applied the cream or a placebo once daily for 8 weeks. The goal was to see if the cream could clear or nearly clear the skin rash better than the placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tapinarof cream, 1%
What this could lead to
If successful, this could provide a new topical treatment option for people with moderate to severe eczema, potentially reducing symptoms like redness and itching.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The cream may not work for everyone, and side effects like skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

407 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Dermavant Investigative Site

    Birmingham, Alabama, 35244, United States

  • Dermavant Investigative Site

    Phoenix, Arizona, 85032, United States

  • Dermavant Investigative Site

    Bryant, Arkansas, 72022, United States

  • Dermavant Investigative Site

    Beverly Hills, California, 90212, United States

  • Dermavant Investigative Site

    Fountain Valley, California, 92708, United States

  • Dermavant Investigative Site

    Fremont, California, 94538, United States

  • Dermavant Investigative Site

    Inglewood, California, 90301, United States

  • Dermavant Investigative Site

    Los Angeles, California, 90017, United States

  • Dermavant Investigative Site

    Los Angeles, California, 90033, United States

  • Dermavant Investigative Site

    Mission Viejo, California, 92691, United States

  • Dermavant Investigative Site

    Sacramento, California, 95815, United States

  • Dermavant Investigative Site

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

  • Dermavant Investigative Site

    Boca Raton, Florida, 33431, United States

  • Dermavant Investigative Site

    Boca Raton, Florida, 33486, United States

  • Dermavant Investigative Site

    Brandon, Florida, 33511, United States

  • Dermavant Investigative Site

    Coral Gables, Florida, 33146, United States

  • Dermavant Investigative Site

    Jacksonville, Florida, 32256, United States

  • Dermavant Investigative Site

    Margate, Florida, 33063, United States

  • Dermavant Investigative Site

    Miami, Florida, 33126, United States

  • Dermavant Investigative Site

    Miami Lakes, Florida, 33014, United States

  • Dermavant Investigative Site

    Orlando, Florida, 32801, United States

  • Dermavant Investigative Site

    Pinellas Park, Florida, 33781, United States

  • Dermavant Investigative Site

    Sweetwater, Florida, 33172, United States

  • Dermavant Investigative Site

    Tampa, Florida, 33615, United States

  • Dermavant Investigative Site

    Marietta, Georgia, 30060, United States

  • Dermavant Investigative Site

    Sandy Springs, Georgia, 30328, United States

  • Dermavant Investigative Site

    Savannah, Georgia, 31406, United States

  • Dermavant Investigative Site

    Plainfield, Indiana, 46168, United States

  • Dermavant Investigative Site

    Louisville, Kentucky, 40217, United States

  • Dermavant Investigative Site

    Owensboro, Kentucky, 42301, United States

  • Dermavant Investigative Site

    Covington, Louisiana, 70433, United States

  • Dermavant Investigative Site

    Monroe, Louisiana, 71201, United States

  • Dermavant Investigative Site

    Largo, Maryland, 20774, United States

  • Dermavant Investigative Site

    Bay City, Michigan, 48706, United States

  • Dermavant Investigative Site

    Clarkston, Michigan, 48346, United States

  • Dermavant Investigative Site

    Warren, Michigan, 48088, United States

  • Dermavant Investigative Site

    Ypsilanti, Michigan, 48197, United States

  • Dermavant Investigative Site

    New Brighton, Minnesota, 55112, United States

  • Dermavant Investigative Site

    Missoula, Montana, 59808, United States

  • Dermavant Investigative Site

    Omaha, Nebraska, 68144, United States

  • Dermavant Investigative Site

    Garden City, New York, 11530, United States

  • Dermavant Investigative Site

    New York, New York, 10075, United States

  • Dermavant Investigative Site

    Bexley, Ohio, 43209, United States

  • Dermavant Investigative Site

    Cleveland, Ohio, 44106, United States

  • Dermavant Investigative Site

    Oklahoma City, Oklahoma, 73071, United States

  • Dermavant Investigative Site

    Oklahoma City, Oklahoma, 73120, United States

  • Dermavant Investigative Site

    Gresham, Oregon, 97030, United States

  • Dermavant Investigative Site

    Portland, Oregon, 97223, United States

  • Dermavant Investigative Site

    Hershey, Pennsylvania, 17033, United States

  • Dermavant Investigative Site

    Greenville, South Carolina, 29615, United States

  • Dermavant Investigative Site

    Knoxville, Tennessee, 37909, United States

  • Dermavant Investigative Site

    Austin, Texas, 78745, United States

  • Dermavant Investigative Site

    Bellaire, Texas, 77401, United States

  • Dermavant Investigative Site

    Cypress, Texas, 77433, United States

  • Dermavant Investigative Site

    Dallas, Texas, 75230, United States

  • Dermavant Investigative Site

    Houston, Texas, 77098, United States

  • Dermavant Investigative Site

    San Antonio, Texas, 78218, United States

  • Dermavant Investigative Site

    San Antonio, Texas, 78229, United States

  • Dermavant Investigative Site

    Sugar Land, Texas, 77479, United States

  • Dermavant Investigative Site

    Richmond, Virginia, 23226, United States

  • Dermavant Investigative Site

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Dermavant Investigative Site

    Burlington, Ontario, L7L 6W6, Canada

  • Dermavant Investigative Site

    Cobourg, Ontario, K9A 0Z4, Canada

  • Dermavant Investigative Site

    Hamilton, Ontario, L8S 1G5, Canada

  • Dermavant Investigative Site

    Oakville, Ontario, L6J 7W5, Canada

  • Dermavant Investigative Site

    Ottawa, Ontario, K2C 3N2, Canada

  • Dermavant Investigative Site

    Montreal, Quebec, H2X 2V1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.