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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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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