Trial | NCT00947362  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    134
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.
Study Started
Aug 31
2004
Study Completion
Dec 31
2007
Last Update
Jul 28
2009
Estimate

Other Electro-thermo-coagulation

Drug DAC N-055

moist wound treatment plus 0.05 % pharmaceutical chlorite

Drug saline

physiological saline

ETC + DAC N-055 Experimental

ETC + physiological saline Active Comparator

Criteria 

Inclusion Criteria:

at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

patients previously treated for leishmania
No Results Posted