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

NCT00947362 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-08-08

No results posted yet for this study

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

OTHER

Electro-thermo-coagulation

DRUG

DAC N-055

moist wound treatment plus 0.05 % pharmaceutical chlorite

DRUG

saline

physiological saline

Sponsors & Collaborators

  • German Medical Service (GMS) in Kabul

    collaborator OTHER

  • University of Freiburg

    collaborator OTHER

  • Waisenmedizin e. V. Promoting Access to Essential Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-01
Primary Completion
2007-12-15
Completion
2007-12-15

Countries

  • Afghanistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947362 on ClinicalTrials.gov