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

NCT ID: NCT00947362

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-01

Study Completion Date

2007-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ETC + DAC N-055

Group Type EXPERIMENTAL

Electro-thermo-coagulation

Intervention Type OTHER

DAC N-055

Intervention Type DRUG

moist wound treatment plus 0.05 % pharmaceutical chlorite

ETC + physiological saline

Group Type ACTIVE_COMPARATOR

Electro-thermo-coagulation

Intervention Type OTHER

saline

Intervention Type DRUG

physiological saline

Interventions

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Electro-thermo-coagulation

Intervention Type OTHER

DAC N-055

moist wound treatment plus 0.05 % pharmaceutical chlorite

Intervention Type DRUG

saline

physiological saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* at least one suspected lesion positive in Giemsa smear

Exclusion Criteria

* patients previously treated for leishmania
Minimum Eligible Age

5 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Medical Service (GMS) in Kabul

OTHER

Sponsor Role collaborator

University of Freiburg

OTHER

Sponsor Role collaborator

Waisenmedizin e. V. Promoting Access to Essential Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kurt-Wilhelm Stahl

Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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German Medical Service

Kabul, Kabul, Afghanistan

Site Status

Countries

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Afghanistan

References

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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.

Reference Type DERIVED
PMID: 24551257 (View on PubMed)

Other Identifiers

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No grant or contract number

Identifier Type: -

Identifier Source: secondary_id

169/04

Identifier Type: -

Identifier Source: org_study_id

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