Evidence map›Paper›PMID 40696240›Full record

ArticleDermatology and therapy2025

Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials.

Andrew F Alexis, Leon Kircik, Raj Chovatiya, Zakiya P Rice, Weily Soong, Tina Bhutani, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman and 1 more

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05014568 phase3completednot on this map

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults

TypeinterventionalSponsorOrganon and CoRan2021 to 2023Enrolled407ConditionsAtopic DermatitisArmstapinarof cream, 1%, Vehicle cream
NCT05032859 phase3completednot on this map

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults

TypeinterventionalSponsorOrganon and CoRan2021 to 2023Enrolled406ConditionsAtopic DermatitisArmstapinarof cream, 1%, vehicle cream
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Andrew F AlexisDepartment of Dermatology, Weill Cornell Medicine, 1305 York Avenue, New York, NY, 10021, USA. drandrewalexis@gmail.com.ORCID http://orcid.org/0000-0002-1351-9165
Leon KircikIcahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID http://orcid.org/0000-0002-0831-2151
Raj ChovatiyaChicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA.ORCID http://orcid.org/0000-0001-6510-399X
Zakiya P RiceDermatology Associates of Georgia, Atlanta, GA, USA.
Weily SoongAllerVie Health and Clinical Research, Birmingham, AL, USA.ORCID http://orcid.org/0000-0002-2701-7035
Tina BhutaniUniversity of California, San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-8187-1024
Philip M BrownDermavant Sciences, Inc, Morrisville, NC, USA.
Stephen C PiscitelliDermavant Sciences, Inc, Morrisville, NC, USA.ORCID http://orcid.org/0000-0002-4528-3273
David S RubensteinDermavant Sciences, Inc, Morrisville, NC, USA.ORCID http://orcid.org/0000-0003-0302-8722
Anna M TallmanDermavant Sciences, Inc, Morrisville, NC, USA.ORCID http://orcid.org/0000-0001-9535-0414
April W ArmstrongUniversity of California Los Angeles, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0003-0064-8707

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with atopic dermatitis (AD) and skin of color have heterogeneous presentations and treatment outcomes, however, they are underrepresented in trials. In the ADORING 1 and 2 phase 3, 8-week randomized trials, tapinarof cream 1% once daily (QD) demonstrated superior efficacy versus vehicle in adults and children down to age 2 years with AD. These analyses evaluate efficacy of tapinarof cream 1% QD stratified by race and Fitzpatrick skin type.

methodsThe primary endpoint was a Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at week 8. Secondary endpoints included achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI75). Efficacy evaluations used race categories of Asian, Black or African American, and white, and Fitzpatrick skin types I-III and IV-VI.

resultsIn ADORING 1 and 2, 407 and 406 patients were randomized to tapinarof or vehicle QD (7.3-17.0% Asian; 25.9-35.1% Black/African American 43.0-57.7% white), respectively. Across trials, > 50% had Fitzpatrick skin types IV-VI. Tapinarof demonstrated significant efficacy in adults and children. By race in both trials, the primary endpoint was met by consistently higher proportions treated with tapinarof than vehicle: Asian, 39.5-48.9% versus 3.7-18.5%; Black/African American, 43.1-47.0% versus 17.5-24.1%; white, 49.4-52.1% versus 12.2-14.5%, respectively. Similar, superior responses were reported across Fitzpatrick skin type groups with tapinarof versus vehicle: I-III, 44.8-49.9% versus 13.5-17.7%; IV-VI, 46.8-49.6% versus 15.3-19.5%. EASI75 responses were similarly higher and consistent with tapinarof versus vehicle. Adverse events were mostly mild or moderate, leading to low trial discontinuations (lower with tapinarof than vehicle).

conclusionsTapinarof demonstrated consistent efficacy and was well tolerated versus vehicle in a large, diverse population with AD, regardless of race or Fitzpatrick skin type.

trial registrationClinicaltrials.gov, NCT05014568, NCT05032859. Graphical Abstract avaliable for this article.

Indexed as

Aryl hydrocarbon receptor agonistAtopic dermatitisAtopic eczemaDiverse populationFitzpatrick skin typeRandomized controlled phase 3 trialsSkin of colorTapinarof cream 1% once dailyTopical therapy

Identifiers

PMID40696240
PMCPMC12354664

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.