Efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment in the treatment of mild to moderate psoriasis vulgaris: A randomized, single-blind, multicenter clinical trial

Dermatol Ther. 2018 Sep;31(5):e12632. doi: 10.1111/dth.12632. Epub 2018 Sep 25.

Abstract

To assess the efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment and calcipotriol/betamethasone dipropionate ointment in the treatment of mild-to-moderate patients with psoriasis vulgaris. This was a randomized, single-blind, multicenter clinical trial. A total of 240 patients were randomized to receive twice-daily all-trans retinoic acid/Clobetasol Propionate Compound Ointment (treatment group) or once-daily calcipotriol/betamethasone dipropionate ointment (control group) for 4 weeks. The efficacy, safety, and cost-effectiveness were assessed at Weeks 2 and 4. After 4 weeks, both groups showed a significant clinical improvement compared to baseline (88.33% vs. 89.83%, respectively, p = .7112). But PASI 75 response in the treatment group was superior to the control group (44.12% vs. 28.57%, respectively, p = .0200), at Week 4. SSRI improvement rate in the treatment group was also superior to control group (67.11% vs. 59.43%, respectively, p = .0119) at Week 4. All-trans retinoic acid/Clobetasol Propionate Compound Ointment showed a significant clinical improvement in erythema, infiltration, and scales of skin lesions and PASI score compared to baseline. 1.67% of patients (treatment group) reported adverse reactions compared to 2.50% (control group) with no statistical significance. In addition, the cost-effectiveness assessment showed a higher cost-effectiveness of the treatment group compared to the control group in 4 weeks (199.25 vs. 801.51). All-trans retinoic acid/Clobetasol Propionate Compound Ointment was effective and safe in the treatment of psoriasis vulgaris with similar efficacy as calcipotriol/betamethasone dipropionate ointment and lower treatment costs.

Keywords: all-trans retinoic acid/Clobetasol Propionate Compound Ointment; calcipotriol/betamethasone dipropionate ointment; psoriasis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / economics
  • Anti-Inflammatory Agents / therapeutic use*
  • Betamethasone / adverse effects
  • Betamethasone / analogs & derivatives*
  • Betamethasone / economics
  • Betamethasone / therapeutic use
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Calcitriol / economics
  • Calcitriol / therapeutic use
  • Clobetasol / adverse effects
  • Clobetasol / economics
  • Clobetasol / therapeutic use*
  • Cost-Benefit Analysis
  • Dermatologic Agents / economics
  • Dermatologic Agents / therapeutic use
  • Drug Combinations
  • Female
  • Humans
  • Keratolytic Agents / adverse effects
  • Keratolytic Agents / economics
  • Keratolytic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Ointments
  • Psoriasis / drug therapy*
  • Severity of Illness Index
  • Single-Blind Method
  • Tretinoin / adverse effects
  • Tretinoin / economics
  • Tretinoin / therapeutic use*
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Dermatologic Agents
  • Drug Combinations
  • Keratolytic Agents
  • Ointments
  • betamethasone dipropionate, calcipotriol drug combination
  • Tretinoin
  • Betamethasone
  • Clobetasol
  • Calcitriol