Abstract: Chen Jing, Li Zhenlu, Zhu Xuefeng, Wu Huajuan, Wang Li, Wang Yuping. Department of Dermatology, Henan Provincial People′s Hospital （People′s Hospital of Zhengzhou University）, Zhengzhou 450003, China Corresponding author: Wang Yuping, Email: wyp110@163.com 【Abstract】 Objective To estimate the efficacy and safety of 5-aminolevulinic acid-based photodynamic therapy （ALA-PDT） in the treatment of lichen sclerosus et atrophicus of the vulva. Methods An open and non-controlled clinical study was performed. Forty-two patients were enrolled in this study and received ALA-PDT once every two weeks for 2 to 4 times. Follow-up visits were arranged at 2, 4 and 8 weeks after initiation of treatment, and patients were evaluated at the baseline （before treatment） and all the follow-up time points for the efficacy and safety of treatment. Results Finally, 38 patients completed the trial and 4 patients were lost to follow up. The total response rate was 81.6% （31/38） at the end of the treatment. The average symptom and sign score in these patients was significantly lower at 2, 4 and 8 weeks after initiation of treatment than that before treatment （17.6 ± 10.18, 11.6 ± 8.35 and 7.6 ± 5.93 vs. 29.3 ± 9.17, t = 5.26, 8.80, 12.22, respectively, all P < 0.01）. A significant improvement was also observed in the other aspects, such as skin lesion area, hypopigmentation, erosion/rhagades and itching score at 2, 4 and 8 weeks, as well as in skin atrophy at 8 weeks after initiation of treatment compared with those before treatment （all P < 0.05）. Local burning sensation was the main adverse reaction to ALA-PDT, and 16% （6/38） of these patients complained of severe pain during the first treatment. Conclusion ALA-PDT shows favorable efficacy in patients with lichen sclerosus et atrophicus of the vulva with a rapid onset of action.

Key words: Lichen sclerosus et atrophicus of the vulva, Aminolevulinic acid, Photochemotherapy