Abstract: 【Abstract】 Objective To evaluate the clinical efficacy and safety of tea polyphenol antioxidant gel combined with narrow-band ultraviolet B in the treatment of vitiligo. Methods A single-center, randomized controlled clinical trial was conducted. From April 25 to June 27, 2024, patients with vitiligo were selected from the Department of Dermatology, Hangzhou Third People′s Hospital. An open-label and researcher-blinded design was used. The patients were divided into 3 groups: a phototherapy alone group, a tea polyphenol antioxidant gel combined with phototherapy group, and an antioxidant gel containing superoxide dismutase combined with phototherapy group （positive control group）, with a treatment duration of 3 months. The efficacy was evaluated using the Vitiligo Area Scoring Index （VASI）, with a VASI improvement rate of ≥ 10% being considered as effective treatment. Changes in skin aging and skin barrier function indicators before and after treatment were assessed for 72 vitiligo lesions treated with tea polyphenol antioxidant gel combined with phototherapy and 72 lesions treated with phototherapy alone. Comparisons between the groups were performed using one-way analysis of variance, Fisher's exact test, chi-square test, or t test. Results A total of 171 vitiligo patients with 307 target lesions were successfully followed up in this study, including 74 males and 97 females, and their ages ranged from 1 to 64 years. Among the 307 lesions, 95 were treated with phototherapy alone, of which 35 showed improvement, resulting in a total response rate of 36.8% and an average VASI improvement rate of 10.9%; adverse reactions occurred in 29 lesions （30.5%）. A total of 138 lesions were treated with tea polyphenol antioxidant gel combined with phototherapy, with 73 showing improvement, resulting in a total response rate of 52.9% and an average VASI improvement rate of 24.0%; adverse reactions occurred in 10 lesions （7.2%）. In the positive control group, 74 lesions were treated, with 40 showing improvement, resulting in a total response rate of 54.1% and an average VASI improvement rate of 18.3%; adverse reactions occurred in 5 lesions （6.8%）. Compared with the phototherapy alone group, the tea polyphenol antioxidant gel combined with phototherapy group showed a significantly increased total response rate and VASI improvement rate （both P < 0.01）, but significantly decreased incidence of adverse reactions （P < 0.001）. No significant differences were observed between the tea polyphenol antioxidant gel combined with phototherapy group and the positive control group （all P > 0.05）. In addition, the changes in skin barrier function and skin aging indicators （except for wrinkle depth） before and after treatment were significantly reduced in the tea polyphenol antioxidant gel combined with phototherapy group compared to the phototherapy alone group （all P < 0.05）. After the phototherapy alone, the transepidermal water loss significantly increased （P = 0.004）, and the water content of the stratum corneum significantly decreased （P = 0.012）. However, no significant differences in skin barrier function and skin aging indicators were found before and after treatment in the tea polyphenol antioxidant gel combined with phototherapy group （P > 0.05）. Conclusion The tea polyphenol antioxidant gel can effectively improve the efficacy of narrow-band ultraviolet B in the treatment of vitiligo, and alleviate skin aging and barrier damage caused by phototherapy.

Key words: Vitiligo, Ultraviolet therapy, Antioxidants, Treatment outcome, Aging, Skin barrier, Tea polyphenols