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

July 27, 2009 updated by: Waisenmedizin e. V. Promoting Access to Essential Medicine

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Afghanistan
      • Kabul, Afghanistan
        • German Medical Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

  • patients previously treated for leishmania

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETC + DAC N-055
Other: Electro-thermo-coagulation
Drug: DAC N-055
moist wound treatment plus 0.05 % pharmaceutical chlorite
Active Comparator: ETC + physiological saline
Other: Electro-thermo-coagulation
Drug: saline
physiological saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Wound closure time

Secondary Outcome Measures

Outcome Measure
Leishmania load parasites per gram of tissue before and after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine

Collaborators

University of Freiburg
Waisenmedzin eV PACEM non-profit German NGO
German Medical Service (GMS) in Kabul
Microbiology Institute Clinical Microbiology Immunology and Hygiene University Clinic of Erlangen Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2009

Last Update Submitted That Met QC Criteria

July 27, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 169/04
  • No grant or contract number

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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