Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind, randomized, vehicle-controlled study

J Cosmet Dermatol. 2023 Jul;22(7):2050-2053. doi: 10.1111/jocd.15693. Epub 2023 Mar 21.

Abstract

Introduction: Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis-prone scalp.

Objective: To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.

Materials and methods: A single-center, randomized, double-blind, vehicle-controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis-specific quality-of-life issues using SCALPDEX and product acceptability.

Results: The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject-reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL.

Conclusion: The active shampoo significantly improved clinical signs, symptoms, and QoL of mild-to-moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.

Keywords: dermocosmetic; psoriasis; randomized double-blind study; salicylic acid; scalp.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Dermatologic Agents* / therapeutic use
  • Double-Blind Method
  • Excipients
  • Hair Preparations* / adverse effects
  • Humans
  • Immunoglobulin A / therapeutic use
  • Inflammation
  • Keratolytic Agents / adverse effects
  • Psoriasis* / diagnosis
  • Psoriasis* / drug therapy
  • Quality of Life
  • Scalp Dermatoses* / diagnosis
  • Scalp Dermatoses* / drug therapy
  • Treatment Outcome

Substances

  • Keratolytic Agents
  • Dermatologic Agents
  • Excipients
  • Immunoglobulin A
  • Hair Preparations