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

Background

Treatment with fluocinolone acetonide, hydroquinone, and tretinoin cream is considered the best option for melasma. However, we need more information about how this treatment works for Chinese patients, as their skin may respond differently than that of Caucasian patients.

Aim

The goal of this study was to assess how effective and safe fluocinolone acetonide, hydroquinone, and tretinoin creams are for Chinese patients suffering from moderate to severe melasma.

Methods

We included 53 patients in the study. They were given either a generic cream (triple combination cream), a brand name cream (TRI-LUMA), or a placebo (inactive treatment) once a day for 8 weeks. We measured the effectiveness of the treatments at 4 and 8 weeks using specific scales for melasma severity. We also monitored any side effects that occurred during the treatment.

Results

The generic cream showed a 52.2% effectiveness, while the brand name cream had a 57.1% effectiveness. The side effects were similar between the two active treatments, with 69.6% of patients experiencing side effects from the generic cream and 90.5% from the brand name cream. The placebo group did not report any side effects.

Conclusion

The generic cream was found to be just as effective as the brand name cream and had a similar safety profile for Chinese patients with moderate to severe melasma.

Opportunities Based on Trial Data

Clinics can use this data to set clear goals for treating melasma in Chinese patients, ensuring that they choose effective and safe treatment options.