The Effectiveness of Extract Topical Formulation on the Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial.

OBJECTIVE

Despite many attempts to treat leishmaniasis, new approaches are necessary to reduce the burden of disease. (Brazambel) has shown significant effects against parasites in some studies. This study aimed to investigate the effects of extract topical formulation on cutaneous leishmaniasis.

METHODS

In this randomized controlled clinical trial, patients with cutaneous leishmaniasis were assigned to experimental ( = 18) and control ( = 18) groups. Both groups received intralesional meglumine antimoniate (Glucantime). The experimental group also received 5% Brazambel extract ointment once a day. The interventions continued until the complete healing of the lesions (reepithelialization) for a maximum of 8 weeks. The clinical response, defined as complete response (reepithelialization >75%), partial response (reepithelialization 50%-75%), or treatment failure (reepithelialization <50%), was compared between the groups.

FINDINGS

The percentage of reepithelialization in the experimental group (4 week: 64.44 ± 25.13; 8 week: 83.85 ± 11.54) was higher than the control group (4 week: 53.97 ± 25.88; 8 week: 76.27 ± 21.67); however, the differences were not statistically significant ( = 0.252 and 0.494, respectively). Moreover, there was no significant difference between the experimental and control groups regarding the rate of complete healing (88.9% vs. 72.2%, respectively).

CONCLUSION

The use of extract 5% topical formulation does not affect the healing of cutaneous leishmaniasis.