A double‐blind, placebo‐controlled randomized trial of skin‐lightening cream containing lycopene and wheat bran extract on melasma

Abstract Objective Melasma is an acquired hyperpigmentation disorder, and reactive oxygen species play important role in regulating melanin synthesis. Lycopene is one of the most effective oxygen neutralizers among tomato‐derived carotenoids. Also, hydroquinone is a compound that has been used for the treatment of hyperpigmentation by mechanism of tyrosinase inhibition and can be found in wheat. Methods An appropriate cream formulation containing 0.05% tomato lycopene and 3.45% wheat bran extract was prepared, and physicochemical characterization was performed. The prepared formulations were applied twice a day for three months in combination with SPF = 30 sunscreen by 22 patients diagnosed with melasma. MASI score in two groups was evaluated at weeks 0, 3, 6, 9, and 12 and 1 month after the treatment. Results The prepared formulation shows smooth and homogeneous appearance with suitable spreadability and viscosity. The MASI score of intervention group from the sixth week until the end of the treatment was significantly decreased compared to the onset of the treatment ( P < .05), and the mean difference of the MASI score and the rate of skin discoloration in intervention group (0.53 ± 0.47 and 3.73 ± 1.90, respectively) were significantly higher than in placebo group (0.14 ± 0.20 and 0.91 ± 0.07, respectively; P < .05). Size of melasma during the study was decreased significantly from 6.59 ± 3.47 to 5.97 ± 3.83 ( P < .05). Conclusion The data of mean difference of the MASI score indicated skin improvement in intervention group. Meanwhile, no recurrence was observed one month after the end of the treatment. These data suggest that the prepared formulation containing lycopene and wheat bran extract is safe and could be promising as an efficacious cosmetic treatment.