Abstract:Objective To explore the efficacy and safety of 5-aminolevulinic acid hydrochloride photodynamic therapy (ALA-PDT) in the treatment of lichen sclerosus vulva (LS). Methods Forty patients diagnosed with lichen sclerosus vulva were randomly divided into an experimental group and a control group with 20 patients in each group. The patients in the experimental group were treated with 20% ALA-PDT every 2 weeks for 6 times. The patients in the control group were treated with 0.1% Tacrolimus ointment in any on-spot treatment, twice per day for 3 months. The treatment effect and adverse reactions were observed in both groups. Results In each group, 19 patients completed the treatment. The total effective rate was 89.47% (17/19) in the experimental group and 78.95% (15/19) in the control group, there was a significant difference in therapeutic effect between the two groups (P < 0.05). In the experimental group, the lesion area was (2.89 ± 3.25) cm2, white spot score was (1.67 ± 1.21), pruritus score was (0.87 ± 1.32), symptoms/signs score was (7.64 ± 5.63); while in the control group the lesion area was (4.15 ± 3.04) cm2, white spot score was (2.98 ± 1.05), pruritus score was (1.45 ± 1.24), symptoms/signs score was (9.72 ± 6.47), the differences between the two groups were statistically significant (P < 0.05). There was no obvious adverse reaction in either group. Conclusions ALA-PDL is an effective and safe method for the treatment of LS.