Evidence map›Paper›PMID 34713415›Full record

Trial reportAmerican journal of clinical dermatology2022

Tapinarof Cream 1% for Extensive Plaque Psoriasis: A Maximal Use Trial on Safety, Tolerability, and Pharmacokinetics.

John E Jett, Michael McLaughlin, Mark S Lee, Lawrence Charles Parish, Janet DuBois, Tooraj Joseph Raoof, Glenn Tabolt, Timothy Wilson, Matthew C Somerville, Wayne DellaMaestra and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04042103 (Open-Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.1field-weighted citation impact, top 12% of its field
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.

NCT04042103 phase2completednot on this map

Open-Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

TypeinterventionalSponsorOrganon and CoRan2019 to 2020Enrolled21ConditionsPlaque PsoriasisArmsTapinarof cream, 1%
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Signaling pathways and targeted therapies for psoriasis.Signal transduction and targeted therapy · 2023
    Review
  13. Article
  14. Review
  15. Tapinarof for the treatment of psoriasis.Dermatologic therapy · 2022
    Review
  16. Journal of clinical medicine · 2022
    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 at 4 institutions in 1 country.

John E JettDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0002-1940-457X
Michael McLaughlinDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0002-5628-1564
Mark S LeeProgressive Clinical Research, San Antonio, TX, USA.ORCID http://orcid.org/0000-0001-8281-0039
Lawrence Charles ParishPaddington Testing Company, Inc, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0002-4612-1508
Janet DuBoisDermResearch, Inc, Austin, TX, USA.ORCID https://orcid.org/0000-0002-7487-7716
Tooraj Joseph RaoofT. Joseph Raoof MD, Inc, Encino, CA, USA.ORCID http://orcid.org/0000-0001-8634-4303
Glenn TaboltDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0002-9668-8270
Timothy WilsonDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0001-7085-7462
Matthew C SomervilleDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0001-5315-3164
Wayne DellaMaestraDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0002-9559-9815
Stephen C PiscitelliDermavant Sciences, 3300 Paramount Parkway, STE 150, Morrisville, NC, 27560, USA. steve.piscitelli@dermavant.com.ORCID http://orcid.org/0000-0002-4528-3273
Roivant Sciences (United States) · USDermResearch (United States) · USFreedom to Live · USProgressive Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTapinarof is a novel topical therapeutic aryl hydrocarbon receptor modulating agent in development for the treatment of psoriasis and atopic dermatitis.

objectiveThis multicenter, open-label trial assessed the safety, tolerability, pharmacokinetics (PK), and efficacy of tapinarof cream 1% once daily (QD) under maximal use conditions in extensive plaque psoriasis.

methodsAdults with a baseline Physician Global Assessment (PGA) score of ≥ 3 and body surface area (BSA) involvement ≥ 20% received tapinarof cream 1% QD for 29 days. Safety and tolerability assessments included adverse events (AEs) and local tolerability scales. PK parameters were calculated using non-compartmental analysis. Efficacy assessments included change in PGA, Psoriasis Area and Severity Index score, and %BSA affected.

resultsTwenty-one patients were enrolled. Common AEs were folliculitis, headache, back pain, and pruritus (none led to discontinuation). Tapinarof plasma exposure was low, with the majority of concentrations being below detectable limits. At day 29, 14 patients (73.7%) had a ≥ 1-grade improvement in PGA score and six patients (31.6%) had a ≥ 2-grade improvement; four patients (21.1%) achieved treatment success (PGA 0 or 1 and ≥ 2-grade improvement).

conclusionTapinarof cream 1% QD was well tolerated, with limited systemic exposure and significant efficacy at 4 weeks in patients with extensive plaque psoriasis. ClinicalTrials.gov Identifier NCT04042103.

Indexed as

Dermatologic AgentsHumansPsoriasisResorcinolsSeverity of Illness IndexSkin CreamStilbenesDermatologic AgentsResorcinolsStilbenestapinarof

Identifiers

PMID34713415
PMCPMC8776723
OpenAlexW3210474771

What OpenQuestion holds

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LicenceCC BY-NC
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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.