Evaluating the efficacy and safety of vascular IPL for treatment of acute cutaneous leishmaniasis: a randomized controlled trial.

Abstract

Treatment of cutaneous leishmaniasis (CL) continues to be a health concern, and alternative therapies with fewer side effects are substantially needed. This study aimed to determine the efficacy of intense pulsed light (IPL) with wavelength spectrum affecting vascular lesions on acute cutaneous leishmaniasis. In this randomized clinical trial study, 30 patients with acute CL were enrolled. Baseline clinical and demographic data were recorded in the checklist after obtaining written informed consent. Patients were randomly allocated to receive either IPL fortnightly (intervention group) or intralesional meglumine antimoniate (MA) weekly (control group) over 10weeks. Patients were assessed every 2weeks to determine the size of induration and improvement rate of lesions. Follow-up visits were arranged at 3rd and 6th months. Overall, 15 patients (21 lesions) in the intervention group and 15 patients (22 lesions) in the control group were studied. The size of lesions in the control group was significantly higher at the baseline (P = 0.014) and the second week (P = 0.034), and significantly lower in the eighth week (P = 0.009), compared with the intervention group. The size of lesions in the control group changed during the study (P < 0.001), whereas changes were not significant in the intervention group. The trend of changes in size of lesions was faster in the control group (P < 0.001). More patients in the control group had higher improvement rate at the sixth (P = 0.005) and tenth (P < 0.001) weeks. At the end of study, the cure rate was 35% (7 out of 20 lesions) in intervention group and 81.8% (18 out of 22 lesions) in the control group. Complete response happened earlier in the control group (P < 0.001). None of the lesions that were cured before the tenth week relapsed after 6months. The frequency of blistering was significantly higher in intervention group (P = 0.001). Our results indicated that IPL with wavelength spectrum affecting vascular lesions was inferior to intralesional MA in treatment of CL. However, it can be considered as a second-line option, especially in patients with limitations for use of MA. Trial registry: https://www.irct.ir/trial/34246 IRCT20140414017271N5.