Clinical Effect of Intralesional Levofloxacin Injection for Cutaneous Leishmaniasis Management: Open-label Single-arm Trial

What this Trial Is About

Researchers are evaluating the effectiveness of intralesional levofloxacin 0.5% solution as a local injection for treating cutaneous leishmaniasis. This open-label, single-arm clinical trial focuses on patients with cutaneous leishmaniasis lesions, aiming to assess the cure rate of the treatment over a period of up to 90 days or until the lesions heal. Local therapies like intralesional drugs are recommended by health organizations as alternatives to systemic treatments due to their lower risk, toxicity, and cost. Participants will receive intralesional levofloxacin injections (5 mg/ml) into each lesion based on its size (5 mg/cm2). The injections will be administered once weekly for up to six weeks, stopping earlier if the lesions are cured before six weeks. A fine insulin needle will be used to infiltrate the lesion thoroughly until the base is completely blanched. No local anesthesia is added, and the drug is injected directly into the lesion, not under the skin. Throughout the study, participants will be asked to return for lesion assessments to monitor healing progress. The primary outcome is the cure rate from enrollment to the end of treatment within 90 days. The trial lasts up to six weeks of treatment and follow-up until lesions are cured or the 90-day endpoint. Participants' lesions will be carefully monitored to evaluate the treatment's effectiveness and safety during the trial period.

Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis