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

W

Waisenmedizin e. V. Promoting Access to Essential Medicine

Status and phase

Completed
Phase 3
Phase 2

Conditions

Wound Healing

Treatments

Other: Electro-thermo-coagulation
Drug: saline
Drug: DAC N-055

Study type

Interventional

Funder types

Other

Identifiers

NCT00947362
169/04
No grant or contract number

Details and patient eligibility

About

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.

Enrollment

134 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

at least one suspected lesion positive in Giemsa smear

Exclusion criteria

patients previously treated for leishmania

Trial design

134 participants in 2 patient groups

ETC + DAC N-055
Experimental group
Treatment:
Drug: DAC N-055
Other: Electro-thermo-coagulation
ETC + physiological saline
Active Comparator group
Treatment:
Drug: saline
Other: Electro-thermo-coagulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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