Efficacy and Safety of Generic Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream Compared With TRI-LUMA for the Treatment of Moderate-To-Severe Melasma in Chinese Patients: A Randomized, Single-Center, Placebo-Controlled Trial
Abstract
Background: Treatment with fluocinolone acetonide, hydroquinone, and tretinoin cream is the gold standard for melasma; however, the effects of this treatment in the Chinese population remain unclear. Due to the differences between Chinese and Caucasian subjects, further clinical trials in Chinese patients with melasma are needed.
Aim: To evaluate the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin creams in Chinese patients with moderate-to-severe melasma.
Methods: We recruited 53 patients who received a generic formulation (triple combination cream, TCC), brand formulation (TRI-LUMA), or placebo once daily for 8 weeks. In weeks 4 and 8, efficacy was evaluated based on the Melasma Severity Scale and Melasma Area and Severity Index. In addition, safety was assessed based on the incidence and severity of treatment-emergent adverse events.
Results: The generic TCC group achieved 52.2% efficacy compared to 57.1% in the TRI-LUMA group. There was no significant difference in the incidence of adverse effects between the TCC and TRI-LUMA groups (69.6% and 90.5%, respectively; p > 0.05). The incidence of adverse events in the placebo group was 0%.
Conclusion: Generic TCC was as effective as TRI-LUMA and had a similar safety profile in this study of Chinese subjects with moderate-to-severe melasma.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 53 participants or records.
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