Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul
rtt-ACL
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)
2 other identifiers
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2007
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedAugust 8, 2025
August 1, 2025
3.4 years
July 24, 2009
August 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Days for wound closure
Days for primary wound closure
From the day of treatment start to the day of "wound closure"
Secondary Outcomes (1)
Leishmania parasites load per gram of tissue before and after treatment
Before treatment start and at day "wound closure"
Study Arms (2)
ETC + DAC N-055
EXPERIMENTALETC + physiological saline
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- at least one suspected lesion positive in Giemsa smear
You may not qualify if:
- patients previously treated for leishmania
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Medical Service
Kabul, Kabul, Afghanistan
Related Publications (1)
Jebran AF, Schleicher U, Steiner R, Wentker P, Mahfuz F, Stahl HC, Amin FM, Bogdan C, Stahl KW. Rapid healing of cutaneous leishmaniasis by high-frequency electrocauterization and hydrogel wound care with or without DAC N-055: a randomized controlled phase IIa trial in Kabul. PLoS Negl Trop Dis. 2014 Feb 13;8(2):e2694. doi: 10.1371/journal.pntd.0002694. eCollection 2014 Feb.
PMID: 24551257DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 28, 2009
Study Start
August 1, 2004
Primary Completion
December 15, 2007
Study Completion
December 15, 2007
Last Updated
August 8, 2025
Record last verified: 2025-08