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

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ClinicalTrials.gov Identifier: NCT00947362
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
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

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : August 2004
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Wound closure time

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


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

  • patients previously treated for leishmania

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009

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