Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis

J Am Acad Dermatol. 2019 Mar;80(3):714-721. doi: 10.1016/j.jaad.2018.10.037. Epub 2018 Oct 26.


Background: There is a significant need for novel, safe, and efficacious topical treatments for psoriasis.

Objective: We assessed the safety and efficacy of tapinarof in a new cream formulation at 2 concentrations and with 2 application frequencies in adults with psoriasis.

Methods: Double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in adults, with psoriasis with body surface involvement ≥1% and ≤15% and Physician Global Assessment (PGA) score ≥2 at baseline. Primary endpoint included PGA of 0 or 1 at week 12 and a 2-grade improvement from baseline. Additional analyses included assessment of ≥75% improvement of Psoriasis Area and Severity Index and mean percent change in Psoriasis Area and Severity Index and body surface area involvement.

Results: Treatment success defined by PGA 0 or 1 and a 2-grade improvement at week 12 was statistically significantly higher (at a .05 significance level) in the tapinarof groups (65% [1% twice daily], 56% [1% once daily], 46% [0.5% twice daily], and 36% [0.5% once daily]) than in the vehicle groups (11% [twice daily] and 5% [once daily]) and was maintained for 4 weeks posttreatment. Treatment-emergent adverse events were more frequent in patients treated with tapinarof (85/152, 56%) than vehicle (19/75, 25%) and mild-to-moderate in intensity. Severe treatment-emergent adverse events were reported in all tapinarof groups except the 0.5% once daily group.

Limitations: Large confirmation trials are needed.

Conclusions: Tapinarof cream is efficacious and well tolerated in adult patients with psoriasis.

Keywords: GSK2894512; TAMA; psoriasis; tapinarof; therapeutic AhR (aryl hydrocarbon receptor) modulating agent.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Body Surface Area
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Double-Blind Method
  • Humans
  • Middle Aged
  • Psoriasis / drug therapy*
  • Resorcinols / administration & dosage
  • Resorcinols / therapeutic use*
  • Severity of Illness Index
  • Skin Cream / administration & dosage*
  • Skin Cream / adverse effects
  • Stilbenes / administration & dosage
  • Stilbenes / therapeutic use*
  • Young Adult


  • Dermatologic Agents
  • Resorcinols
  • Stilbenes
  • tapinarof