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Completed

NCT Number: NCT00947362

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

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.

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Key information

Conditions

Wound Healing

Age range

5 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

German Medical Service

Kabul, Afghanistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least one suspected lesion positive in Giemsa smear

Exclusion criteria

  • patients previously treated for leishmania

Treatment and study plan

Electro-thermo-coagulation

Other

DAC N-055

Drug

moist wound treatment plus 0.05 % pharmaceutical chlorite

Saline

Drug

physiological saline

Primary outcomes

  1. Days for wound closure

    Time frame: From the day of treatment start to the day of "wound closure"

    Days for primary wound closure

Secondary outcomes

  1. Leishmania parasites load per gram of tissue before and after treatment

    Time frame: Before treatment start and at day "wound closure"

    Parasite load per gram of tissue

Sponsors and collaborators

Lead sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine

Other

Collaborators

  • German Medical Service (GMS) in Kabul
  • University of Freiburg

Registry information

Official study title

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)

Acronym: rtt-ACL

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2009
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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