Randomized, Double-Blinded, Split-Face Study Comparing the Efficacy and Tolerability of Two Topical Products for Melasma

J Drugs Dermatol. 2020 Sep 1;19(9):822-827. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5353.

Abstract

Background: Melasma is a common disorder of hyperpigmentation that disproportionately affects individuals with skin of color. There is a paucity of studies evaluating non-hydroquinone (HQ) topical therapies for the treatment of melasma in darker skin types.

Objective: To compare the safety, efficacy, and tolerability of a HQ-free, retinol-free cosmetic topical brightener (CTB) and HQ 4% in the treatment of moderate symmetric facial melasma in patients with Fitzpatrick skin types (FST) III–VI. Methods & Materials: This was a randomized, double-blinded, split-face clinical trial. Eighteen adult patients with facial melasma were treated with CTB and HQ 4%, each to a different side of the face, twice daily for 12 weeks. Clinical assessments included half-face Melasma Area Severity Index (MASI), Overall Hyperpigmentation scale, and Melasma Severity Rating Scale (MSRS). Patients completed a Melasma Quality of Life (MelasQoL) questionnaire and clinical photographs were taken at each visit.

Results: CTB and HQ 4% demonstrated statistically significant improvements in half-face MASI, Overall Hyperpigmentation, MSRS and MelasQol compared to baseline. HQ 4% showed statistically significant improvements in MSRS at week 12 compared to CTB, but was non-superior for all other clinical endpoints.

Conclusion: HQ-free, retinol-free CTB and HQ 4% both are effective and well-tolerated in the treatment of moderate facial melasma in FST III–VI. J Drugs Dermatol. 2020;19(9):822-827. doi:10.36849/JDD.2020.5353.

Publication types

  • Equivalence Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Face
  • Female
  • Humans
  • Hydroquinones / administration & dosage*
  • Hydroquinones / adverse effects
  • Male
  • Melanosis / diagnosis
  • Melanosis / drug therapy*
  • Melanosis / psychology
  • Middle Aged
  • Photography
  • Quality of Life
  • Severity of Illness Index
  • Skin / diagnostic imaging
  • Skin / drug effects
  • Skin Lightening Preparations / administration & dosage*
  • Skin Lightening Preparations / adverse effects
  • Skin Pigmentation / drug effects*
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Hydroquinones
  • Skin Lightening Preparations
  • hydroquinone