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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

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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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References

  1. Kauvar AN. The evolution of melasma therapy: targeting melanosomes using low-fluence Q-switched neodymium-doped yttrium aluminium garnet lasers. Semin Cutan Med Surg. 2012;31(2):126–32.

    Article  CAS  PubMed  Google Scholar 

  2. Gupta AK, Gover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. J Am Acad Dermatol. 2006;55(6):1048–65.

    Article  PubMed  Google Scholar 

  3. Grimes PE. Melasma: etiologic and therapeutic considerations. Arch Dermatol. 1995;131(12):1453–7.

    Article  CAS  PubMed  Google Scholar 

  4. Vachiramon V, Suchonwanit P, Thadanipon K. Melasma in men. J Cosmet Dermatol. 2012;11(2):151–7.

    Article  PubMed  Google Scholar 

  5. Sivayathorn DA. Melasma in orientals. Clin Drug Invest. 1995;10(2 Suppl):34–40.

    Article  Google Scholar 

  6. Ortonne JP, Arellano I, Berneburg M, Cestari T, Chan H, Grimes P, et al. A global survey of the role of ultraviolet radiation and hormonal influences in the development of melasma. J Eur Acad Dermatol Venereol. 2009;23(11):1254–62.

    Article  CAS  PubMed  Google Scholar 

  7. Goh CL, Dlova CN. A retrospective study on the clinical presentation and treatment outcome of melasma in a tertiary dermatological referral centre in Singapore. Singap Med J. 1999;40(7):455–8.

    CAS  Google Scholar 

  8. Balkrishnan R, Kelly AP, McMichael A, Torok H. Improved quality of life with effective treatment of facial melasma: the pigment trial. J Drugs Dermatol. 2004;3(4):377–81.

    CAS  PubMed  Google Scholar 

  9. Kligman AM, Willis I. A new formula for depigmenting human skin. Arch Dermatol. 1975;111(1):40–8.

    Article  CAS  PubMed  Google Scholar 

  10. Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988;124(6):869–71.

    Article  CAS  PubMed  Google Scholar 

  11. Taylor SC, Torok H, Jones T, Lowe N, Rich P, Tschen E, et al. Efficacy and safety of a new triple-combination agent for the treatment of facial melasma. Cutis. 2003;72(1):67–72.

    PubMed  Google Scholar 

  12. Torok HM, Jones T, Rich P, Smith S, Tschen E. Hydroquinone 4 %, tretinoin 0.05 %, fluocinolone acetonide 0.01 %: a safe and efficacious 12-month treatment for melasma. Cutis. 2005;75(1):57–62.

    PubMed  Google Scholar 

  13. Torok H, Taylor S, Baumann L, Jones T, Wieder J, Lowe N, et al. A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. J Drugs Dermatol. 2005;4(5):592–7.

    PubMed  Google Scholar 

  14. The Pigmentation Disease Division, Committee of Skin and Venereal Disease, China Society of Integrated Traditional Chinese and Western Medicine. The diagnostic and treatment criteria of melasma and leukoderma. Edition 2010 [in Chinese]. Chin J Dermatol. 2010;43(6):373.

    Google Scholar 

  15. Chan R, Park KC, Lee MH, Lee ES, Chang SE, Leow YH, et al. A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01 %, hydroquinone 4 %, tretinoin 0.05 %) compared with hydroquinone 4 % cream in Asian patients with moderate to severe melasma. Br J Dermatol. 2008;159(3):697–703.

    CAS  PubMed  Google Scholar 

  16. Hexsel D, Lacerda DA, Cavallante AS, Machado Filho CA, Kadi LL, Ayres EL, et al. Epidemiology of melasma in Brazilian patients: a multicenter study. Int J Dermatol. 2014;53(4):440–4.

    Article  PubMed  Google Scholar 

Download references

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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Author notes

    Authors and Affiliations

    1. Department of Dermatology, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Guangzhou, 510630, China

      Zijian Gong & Wei Lai

    2. Department of Dermatology, General Hospital of the Air Force, PLA, Beijing, China

      Guang Zhao, Qingqi Yang & Yuping Dang

    3. Skin and Cosmetic Research Department, Shanghai Skin Diseases and STD Hospital, Shanghai, China

      Xuemin Wang & Ying Zou

    4. Department of Dermatology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China

      Min Zheng & Lunfei Liu

    5. Department of Dermatology, West China Hospital of Sichuan University, Chengdu, China

      Li Li

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    1. Zijian Gong
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    2. Wei Lai
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    3. Guang Zhao
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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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    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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    • DOI: https://doi.org/10.1007/s40261-015-0292-8

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