Comparing Ciprofloxacin and Sodium Stibogluconate Injections for Treating Cutaneous Leishmaniasis in Adults

What this Trial Is About

Researchers are evaluating the effectiveness of intralesional ciprofloxacin 0.2% solution compared to intralesional sodium stibogluconate SSG 10% intravenous solution for treating cutaneous leishmaniasis. This phase 2 randomized parallel groups clinical trial aims to compare these two local injection therapies for patients with cutaneous leishmaniasis lesions. Participants are divided into two groups receiving either weekly intralesional injections of ciprofloxacin at a dose of 2 mgcm2 or sodium stibogluconate at 1 mgcm2. Both treatments are given once weekly for up to six weeks. Each lesion is injected using a fine insulin needle until the base is blanched, with volumes ranging from 0.2 to 4.0 ml per lesion depending on size. Treatment stops early if lesions are cured before six weeks. During the study, each lesion is followed for up to 90 days or until it is cured. Patients attend weekly visits for injections and lesion assessments. Researchers measure the cure rate from enrollment to the end of treatment within the 90-day follow-up. Safety and response are closely monitored throughout the study period.

Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate