New cream shows promise for kids with severe eczema
NCT ID NCT05186805
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested a cream called tapinarof in 36 children aged 2 to 17 with severe eczema covering large areas of skin. The goal was to see how much of the drug gets into the body and whether it is safe. Children applied the cream once daily, and researchers monitored side effects and drug levels.
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 point toward a new topical treatment option for children with severe eczema.
- What could go wrong
- This is a small, early-phase study focused on safety and drug levels, not on proving effectiveness. The cream may not work for all children or could cause skin irritation.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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36 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Aug 2022
- 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 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old * BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy. * vIGA-AD score of ≥ 3 at screening and baseline (pre-dose) * Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study * Capable of giving written informed consent * Negative pregnancy test at Baseline (Day 1) 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dermavant Investigative Site
Thousand Oaks, California, 91320, United States
-
Dermavant Investigative Site
Centennial, Colorado, 80112, United States
-
Dermavant Investigative Site
Coral Gables, Florida, 33146, United States
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Dermavant Investigative Site
Hialeah, Florida, 33016, United States
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Dermavant Investigative Site
Miami Lakes, Florida, 33014, United States
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Dermavant Investigative Site
Chicago, Illinois, 60611, United States
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Dermavant Investigative Site
Summerville, South Carolina, 29445, United States
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Dermavant Investigative Site
Houston, Texas, 77030, United States
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Dermavant Investigative Site
San Antonio, Texas, 78213, United States
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Dermavant Investigative Site
Calgary, Alberta, T3A 2N1, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Skin scans may predict who responds to dupilumab for eczema
- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
- Scientists probe whether lebrikizumab rewires diseased skin at the molecular level
- Can a Lab-Made antibody calm severe eczema?
- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?