Efficacy and Safety of Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream in Chinese Patients with Melasma: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study

Abstract

Background and Objectives

This study aimed to determine the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin (FAHT) cream for the treatment of moderate and severe facial melasma. The primary objective was assessment of clinical efficacy, instrumental measured efficacy, and integral therapeutic efficacy at the end of weeks 4 and 8.

Methods

A total of 233 subjects were randomly allocated (1:1 ratio) to receive topically administered FAHT cream (n = 117) or placebo (n = 116) once nightly for 8 weeks. Observed side effects were documented throughout.

Results

In the per protocol set (PPS; those subjects who met all requirements of the protocol), the integral therapeutic efficacy rate of FAHT cream on moderate and severe melasma was 68.57 % (vs. placebo, 0.94 %), the clinical effective rate of FAHT cream was 74.29 % (vs. placebo, 0.94 %), and the instrumental measure efficacy of FAHT cream was 71.43 % (vs. placebo, 6.60 %). The difference in efficacy between the two groups was statistically significant (p < 0.001). In the full analysis set (FAS; the PPS and those subjects who were lost to follow-up but received at least one study treatment), the integral therapeutic efficacy rate of FAHT cream was 64.60 % (vs. placebo, 0.88 %), the clinical effective rate of FAHT cream was 69.91 % (vs. placebo, 0.88 %), and the instrumental measure efficacy of FAHT cream was 69.03 % (vs. placebo, 7.08 %). The difference in efficacy between the two groups was statistically significant (p < 0.001). Of 113 subjects in the FAHT group, 34 (30.1 %) reported adverse effects. Most of the pathological adverse effects were mild and resolved with either continuous treatment or discontinuation. Of 113 subjects in the placebo group, three (2.6 %) reported mild adverse effects. No severe adverse effects or other abnormal clinical results were associated with the study treatment.

Conclusion

FAHT cream is efficacious, well tolerated, and has a high margin of safety for the treatment of moderate and severe melasma in the Chinese population.

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Acknowledgments

All authors participated in the conception, design, and implementation of the trials, and were involved in the interpretation of analyzed data and the decision to submit for publication.

Conflict of interest

Zijian Gong, Wei Lai, Guang Zhao, Xuemin Wang, Min Zheng, Li Li, Qingqi Yang, Yuping Dang, Lunfei Liu, and Ying Zou have no conflicts of interest to declare.

Funding

Zhejiang Rishengchang Pharmaceutical Co., Ltd was the sponsor of this study and supplied the study drug and the placebo.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee as well as the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Corresponding authors

Correspondence to Zijian Gong or Wei Lai.

Additional information

China Food and Drug Administration (CFDA) Trial Registration Number: 2008L01344.

Z. Gong and W. Lai contributed equally to this article.

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40261_2015_292_MOESM1_ESM.pdf

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Gong, Z., Lai, W., Zhao, G. et al. Efficacy and Safety of Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream in Chinese Patients with Melasma: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study. Clin Drug Investig 35, 385–395 (2015). https://doi.org/10.1007/s40261-015-0292-8

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Keywords

  • Hydroquinone
  • Effective Rate
  • Tretinoin
  • Azelaic Acid
  • Kojic Acid