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

Wound Healing Clinical Trial

— rtt-ACL  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947362
• Other study ID #: 169/04
• Secondary ID: No grant or cont
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 24, 2009
• Last updated: July 27, 2009
• Start date: August 2004
• Est. completion date: December 2007

Study information

• Verified date: July 2009
• Source: Waisenmedizin e. V. Promoting Access to Essential Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAfghanistan: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2007
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

• patients previously treated for leishmania

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous
• Wound Healing

Intervention

Other:
• Electro-thermo-coagulation

Drug:
• DAC N-055
moist wound treatment plus 0.05 % pharmaceutical chlorite
• saline
physiological saline

Locations

Country	Name	City	State
Afghanistan	German Medical Service	Kabul

Sponsors (5)

Lead Sponsor	Collaborator
Waisenmedizin e. V. Promoting Access to Essential Medicine	German Medical Service Kabul GMS non-profit Afghan NGO, Microbiology Institute Clinical Microbiology Immunology and Hygiene University Clinic of Erlangen Germany, University of Freiburg, Waisenmedzin eV PACEM non-profit German NGO

Country where clinical trial is conducted

Afghanistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound closure time
Secondary	Leishmania load parasites per gram of tissue before and after treatment