NCT06695143

Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia. The study will compare three treatment groups: * Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks. * Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks. * Control Group: SSG only, with no topical treatment. The primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT). A total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.

Conditions

• Leishmaniasis, Cutaneous

Interventions

Type	Name	Description
DRUG	Fusidic Acid	Fusidic acid 2% cream
OTHER	Vehicle cream	Cetomacrogol cream

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2024-11-19
• Last updated: 2024-11-19

Locations

2 sites across 1 country: Ethiopia