Evaluating the efficacy, safety, and tolerability of the combination of tazarotene, azelaic acid, tacrolimus, and zinc oxide for the treatment of melasma: A pilot study

Brandon Kirsch, Paul M. Hoesly, Anokhi Jambusaria-Pahlajani, Michael G. Heckman, Nancy N. Diehl, Jason C. Sluzevich

Research output: Contribution to journalArticle

Abstract

Background: Melasma is a common hyperpigmentation disorder of the skin. Combination therapy of topical retinoids, corticosteroids, and hydroquinone has been effective in treating melasma, but long-term use is limited by corticosteroid atrophy and exogenous ochronosis. The aim of this pilot study (NCT02730819) was to determine the efficacy, safety, and tolerability of a novel composition (2013-MCN-333) comprising tazarotene 0.075%, azelaic acid 20%, tacrolimus 0.1%, and (microfine) zinc oxide 10% for the treatment of melasma. Methods: Sixteen patients with moderate-to-severe melasma were treated daily with sunscreen and 2013-MCN-333 for 20 weeks. Primary outcome measure was change in Melasma Area and Severity Index (MASI) score. Results: Twenty-five percent of patients met the primary endpoint of a MASI score of less than eight points at Week 20. MASI score also decreased significantly from baseline (median: 18.9 points) through Week 4 (median: 17.3 points; p=0.006), Week 12 (median: 16.0 points; p=0.001), and Week 20 (median: 13.3 points; p=0.001). Treatment-related adverse events were mild, most of which decreased or resolved over the course of the study. Limitations: The small sample size and nonblinded nature of treatment intervention are potential limitations. Conclusion: Our results suggest daily 2013-MCN-333 could potentially be an effective, safe, and tolerable treatment for moderate-to-severe melasma.

Original languageEnglish (US)
Pages (from-to)40-45
Number of pages6
JournalJournal of Clinical and Aesthetic Dermatology
Volume12
Issue number5
StatePublished - Jan 1 2019

Fingerprint

Zinc Oxide
Melanosis
Tacrolimus
Safety
Therapeutics
Adrenal Cortex Hormones
Sunscreening Agents
Hyperpigmentation
azelaic acid
tazarotene
Retinoids
Sample Size
Atrophy
Outcome Assessment (Health Care)
Skin

Keywords

  • Aesthetic
  • Cosmetic
  • Drugs
  • Melasma
  • Photosensitivity
  • Tacrolimus

ASJC Scopus subject areas

  • Dermatology

Cite this

Evaluating the efficacy, safety, and tolerability of the combination of tazarotene, azelaic acid, tacrolimus, and zinc oxide for the treatment of melasma : A pilot study. / Kirsch, Brandon; Hoesly, Paul M.; Jambusaria-Pahlajani, Anokhi; Heckman, Michael G.; Diehl, Nancy N.; Sluzevich, Jason C.

In: Journal of Clinical and Aesthetic Dermatology, Vol. 12, No. 5, 01.01.2019, p. 40-45.

Research output: Contribution to journalArticle

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abstract = "Background: Melasma is a common hyperpigmentation disorder of the skin. Combination therapy of topical retinoids, corticosteroids, and hydroquinone has been effective in treating melasma, but long-term use is limited by corticosteroid atrophy and exogenous ochronosis. The aim of this pilot study (NCT02730819) was to determine the efficacy, safety, and tolerability of a novel composition (2013-MCN-333) comprising tazarotene 0.075{\%}, azelaic acid 20{\%}, tacrolimus 0.1{\%}, and (microfine) zinc oxide 10{\%} for the treatment of melasma. Methods: Sixteen patients with moderate-to-severe melasma were treated daily with sunscreen and 2013-MCN-333 for 20 weeks. Primary outcome measure was change in Melasma Area and Severity Index (MASI) score. Results: Twenty-five percent of patients met the primary endpoint of a MASI score of less than eight points at Week 20. MASI score also decreased significantly from baseline (median: 18.9 points) through Week 4 (median: 17.3 points; p=0.006), Week 12 (median: 16.0 points; p=0.001), and Week 20 (median: 13.3 points; p=0.001). Treatment-related adverse events were mild, most of which decreased or resolved over the course of the study. Limitations: The small sample size and nonblinded nature of treatment intervention are potential limitations. Conclusion: Our results suggest daily 2013-MCN-333 could potentially be an effective, safe, and tolerable treatment for moderate-to-severe melasma.",
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