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

Melasma is one of the most common hyperpigmentary disorders found mainly in women and dark-skinned patients. Sunlight, hormones, pregnancy, and genetics remain the most implicated in the causation of melasma. Although rather recalcitrant to treatment, topical agents such as hydroquinone, modified Kligman's Regime, azelaic acid, kojic acid, Vitamin C, and arbutin still remain the mainstay of therapy with sun protection being a cornerstone of therapy. There are several new botanical and non botanical agents and upcoming oral therapies for the future. There is a lack of therapeutic guidelines, more so in the Indian setup. The article discusses available evidence and brings forward a suggested treatment algorithm by experts from Pigmentary Disorders Society (PDS) in a collaborative discussion called South Asian Pigmentary Forum (SPF).

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“…Table 4 summarises the studies which have evaluated the role of triple combination cream in melasma. [ 27 28 29 30 31 32 ]…”

Section: Resultsmentioning

confidence: 99%

Medical management of melasma: A review with consensus recommendations by Indian pigmentary expert group

Sarkar¹,

Gokhale²,

Godse³

et al. 2017

Indian J Dermatol

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“…One RCT 54 compared triple combination cream (TCC) [fluocinolone acetonide 0·01%, hydroquinone (HQ) 4% and tretinoin 0·05%] with placebo. TCC was superior with respect to participants rated as ‘cured or greatly improved’, with RR 79·0 [95% confidence interval (CI) 11·18–558·06; GRADE: ⨁⨁⨁◯; 226 patients] and improvement of total target skin melanin [MD 39·94 (95% CI 25·75–54·13); GRADE: ⨁⨁⨁◯; 211 patients].…”

Section: Resultsmentioning

confidence: 99%

“…After removing duplicates, we screened 813 records and reviewed the full texts of 488 studies (Figure 1). Ultimately, we included 36 studies, reported in 35 articles 42–76 . Detailed information about the study and participant characteristics, including the risk‐of‐bias evaluations and reasons for excluding studies is given in Appendix S3 and Appendix S4 (see Supporting Information).…”

Section: Resultsmentioning

confidence: 99%

Self-applied topical interventions for melasma: a systematic review and meta-analysis of data from randomized, investigator-blinded clinical trials

Pennitz

Kinberger

Valle

et al. 2022

British Journal of Dermatology

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“…Four studies were found evaluating the efficacy of hydroquinone 4% in the treatment of melasma (Table ). Level 1 evidence was presented by Gong Z et al who performed a randomized, placebo‐controlled, double‐blind study lasting 8 weeks in 233 Chinese patients comparing placebo to TCC and showed statistically significant improvement with the treatment cream.…”

Section: Resultsmentioning

confidence: 99%

Melasma: A critical analysis of clinical trials investigating treatment modalities published in the past 10 years

Spierings

2019

J of Cosmetic Dermatology

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Background: Melasma is an acquired disorder of facial pigmentation which is a treatment challenge.Aims: The aim of this article is to critically appraise the clinical trial evidence for different treatment modalities for melasma, published in peer-reviewed journals in the past 10 years. Patients/Methods: The literature review was conducted using PubMed and MEDLINE. The search was performed in July 2019, and search parameters were limited to all English language articles published in the past 10 years only.Results: Eighty-nine clinical trials were found. Four clinical trials investigated topical hydroquinone, supporting its safety and efficacy as first-line treatment. Twelve studies showed tranexamic acid as very promising. Nineteen studies assessed various novel oral, injectable, and topical treatments and highlight some new potential future treatments. Forty-two studies investigated laser and light treatment in melasma:LFQS laser is still one of the best options, especially in darker skin types. However, the picosecond laser has shown excellent results. Finally, 11 studies looked at peels.Overall, peels have not been shown to be superior to the use of topical therapy alone. Conclusion:Topical therapy with a HQ and retinoid-based product should be first line for a minimum of 3 months with the addition of oral tranexamic acid at 250 mg BD if no contraindication. Second-line treatment with lasers includes the LFQS Nd:YAG, picosecond laser, and the pulsed dye laser in lighter skin types. Third-line therapy would be the addition of chemical peels to the above treatments, with GA or TCA peels having the most evidence for effectiveness. K E Y W O R D Shydroquinone, melasma, pigmentation, tranexamic acid, tretinoin | INTRODUC TI ONMelasma is a common, acquired disorder of facial pigmentation which poses one of the greatest treatment challenges to the dermatologist and the aesthetic practitioner. Clinically, it is characterized by irregular brown macules and patches on the face. 1The exact cause is unknown but risk factors for melasma are wellestablished and include a history of sun exposure as well as exposure to visible light, Fitzpatrick skin types greater than III, pregnancy, the use of exogenous hormones such as the oral contraceptive pill and hormone replacement therapy, as well as a family history. 2 There is also emerging evidence for a significant vascular component in

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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

Abstract: 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.

Cited by 15 publications

References 14 publications

Medical management of melasma: A review with consensus recommendations by Indian pigmentary expert group

Medical management of melasma: A review with consensus recommendations by Indian pigmentary expert group

Self-applied topical interventions for melasma: a systematic review and meta-analysis of data from randomized, investigator-blinded clinical trials

Melasma: A critical analysis of clinical trials investigating treatment modalities published in the past 10 years

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