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

This study has been completed.
Sponsor:
Collaborators:
Waisenmedzin eV PACEM non-profit German NGO
German Medical Service Kabul GMS non-profit Afghan NGO
University of Freiburg
Microbiology Institute Clinical Microbiology Immunology and Hygiene University Clinic of Erlangen Germany
Information provided by:
Waisenmedizin e. V. Promoting Access to Essential Medicine
ClinicalTrials.gov Identifier:
NCT00947362
First received: July 24, 2009
Last updated: July 27, 2009
Last verified: July 2009
History of Changes
  Purpose

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.

Condition Intervention Phase
Wound Healing
 Other: Electro-thermo-coagulation
Drug: DAC N-055
Drug: saline
 Phase 2
Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Further study details as provided by Waisenmedizin e. V. Promoting Access to Essential Medicine:

Primary Outcome Measures:
  • Wound closure time

Secondary Outcome Measures:
  • Leishmania load parasites per gram of tissue before and after treatment

Enrollment: 134
Study Start Date: August 2004
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

  • patients previously treated for leishmania
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947362

Locations
Afghanistan
German Medical Service
Kabul, Afghanistan
Sponsors and Collaborators
Waisenmedizin e. V. Promoting Access to Essential Medicine
Waisenmedzin eV PACEM non-profit German NGO
German Medical Service Kabul GMS non-profit Afghan NGO
University of Freiburg
Microbiology Institute Clinical Microbiology Immunology and Hygiene University Clinic of Erlangen Germany
  More Information

No publications provided

Responsible Party: Professor Dr. Dr. Kurt-Wilhelm Stahl President of Waisenmedzin eV
ClinicalTrials.gov Identifier: NCT00947362     History of Changes
Other Study ID Numbers: 169/04, No grant or contract number
Study First Received: July 24, 2009
Last Updated: July 27, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Afghanistan: Ministry of Public Health

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
 Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013