NCT00947362

Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul

Phase 2 Study Electrothermocauterisation of Afghan Patients With Anthroponotic Cutaneous Leishmaniasis With and Without Pharmaceutical Chlorite Listed in the German Drug Codex (DAC N-055)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Waisenmedizin e. V. Promoting Access to Essential Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is: * to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years; * to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.

Conditions

• Wound Healing

Interventions

Type	Name	Description
OTHER	Electro-thermo-coagulation
DRUG	DAC N-055	moist wound treatment plus 0.05 % pharmaceutical chlorite
DRUG	saline	physiological saline

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-12-15
• Completion: 2007-12-15
• First posted: 2009-07-28
• Last updated: 2025-08-08

Locations

1 site across 1 country: Afghanistan