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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Waisenmedizin e. V. Promoting Access to Essential Medicine

Additional 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
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 July 28, 2014