NCT06797544

Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hayder Adnan Fawzi · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study to evaluate the effectiveness of intralesional levofloxacin 0.5% solution as a local injection in treating cutaneous leishmaniasis. In an open-label single-arm clinical trial, all patients were given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured. Intralesional levofloxacin (5 mg/ml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment. A fine insulin needle will be used to infiltrate the lesion.

Detailed description

Local therapies have been recommended by the World Health Organization (WHO), the Pan American Health Organization, and other experts as an alternative to systemic drugs in patients with at least four lesions smaller than 4 cm in diameter, especially when the face or joints are not affected. Usually, they are easy to use and have a lower risk, toxicity, and cost compared to traditional therapies. Local treatment includes thermotherapy, cryotherapy, and topical and intralesional drugs. The last approach is effective and safe in localized forms

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Levofloxacin 0.5%	Intralesional levofloxacin (5 mg/ml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients were only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion. The lesion will be thoroughly infiltrated with the drug solution until the base will be completely blanched. Depending on the lesion size, the amount of solution required ranged from 0.2 to 4.0 ml per lesion. No local anesthesia was added. The solutions were injected intralesionally and not subcutaneously.

Timeline

• Start date: 2025-02-09
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-01-28
• Last updated: 2025-09-30

Locations

1 site across 1 country: Iraq