NCT06798402

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

Effectiveness of Ciprofloxacin Intralesional Injection in the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate: a Parallel Groups Comparative Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Al-Mustafa University College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The Aim of the trial to evaluate the effectiveness of intralesional ciprofloxacin 0.2% solution as a local injection in treating cutaneous leishmaniasis and compare its effect with intralesional sodium stibogluconate (SSG) 10% intravenous solution in cutaneous leishmaniasis as a local injection. In a randomized parallel groups clinical trial, patients were divided into two groups based on therapeutic regimen: 1) intralesional sodium stibogluconate weekly injection and 2) intralesional ciprofloxacin injection. 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.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Ciprofloxacin (BAYO9867)	Intralesional ciprofloxacin (2 mg/ml, 100 ml, Ciproxin®, Bayer Schering pharma AG, Germany), each lesion was injected based on lesion size (2 mg/cm2).
DRUG	sodium stibogluconate (Pentostam)	Intralesional sodium stibogluconate (100 mg/ml, 100 ml vial, Pentostam®, GlaxoSmithKline, UK), each lesion was injected based on lesion size (1 mg/cm2)

Timeline

• Start date: 2025-02-07
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-01-29
• Last updated: 2025-09-30

Locations

1 site across 1 country: Iraq