Evidence map›Paper›PMID 39777610›Full record

ArticleDermatology and therapy2025

Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children.

Eric L Simpson, Adelaide A Hebert, John Browning, Rocco T Serrao, Howard Sofen, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman

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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Review
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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

9 authors.

Eric L SimpsonOregon Health and Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR, 97239-3098, USA. simpsone@ohsu.edu.ORCID http://orcid.org/0000-0003-0853-0252
Adelaide A HebertUTHealth McGovern School of Medicine and Children's Memorial Hermann Hospital, Houston, TX, USA.ORCID http://orcid.org/0000-0002-9167-5729
John BrowningUT Health San Antonio, San Antonio, TX, USA.ORCID http://orcid.org/0000-0002-3708-2252
Rocco T SerraoDermatologists of Southwest Ohio, Mason, OH, USA.
Howard SofenDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0001-7789-6915
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

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2.

methodsIn ADORING 1 and 2, 813 patients were randomized to tapinarof or vehicle QD for 8 weeks. PROs were assessed using the Dermatology Life Quality Index (DLQI), Children's Dermatology Life Quality Index (CDLQI), Infants' Dermatitis Quality of Life Index (IDQOL), Dermatitis Family Impact Questionnaire (DFI), and Patient Oriented Eczema Measure (POEM).

resultsMean baseline DLQI, CDLQI, IDQOL, and DFI scores indicated that the impact on families and patients' quality of life (QoL) of AD was moderate to very large. Mean POEM scores indicated moderate to severe AD symptoms at baseline. Tapinarof improved QoL versus vehicle across all endpoints at week 8: DLQI, - 6.2 vs - 3.5 (P = 0.0031) and - 5.5 vs - 3.5 (P = 0.0028); DFI, - 5.6 vs - 2.9 (P < 0.0001) and - 5.6 vs - 3.8 (P = 0.0037), in ADORING 1 and 2, respectively. Similar improvements in CDLQI and IDQOL were reported with tapinarof versus vehicle. Tapinarof also significantly improved CDLQI, DFI, and POEM sleep subdomain scores versus vehicle. POEM scores also improved with tapinarof versus vehicle: ≥ 12 years, - 9.4 vs - 5.3 and - 10.6 vs - 3.6 (both P < 0.0001); < 12 years, - 11.4 vs - 5.7 (P < 0.0001), and - 10.8 vs - 7.3 (P = 0.0005).

conclusionsTapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD.

trial registrationClinical Trials.gov identifier: NCT05014568; NCT05032859.

Indexed as

Atopic dermatitisFamily impactPatient-reported outcomesQuality of lifeSleep improvementTapinarof cream 1% once dailyTopical aryl hydrocarbon receptor agonist

Identifiers

PMID39777610
PMCPMC11785891

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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 OpenQuestion graph.