Assessment of the efficacy of dressings in the treatment of cutaneous leishmaniasis due to Leishmania major: A randomized, single-blind controlled clinical trial

Phase 2

Conditions: Cutaneous leishmaniasis.

Registration Number: IRCT138707201166N2

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 210

Inclusion Criteria

a) Parasitollogically proven cases of cutaneous leishmaniasis based on positive smear and/or culture b) Otherwise healthy subjects on the basis of medical history c)Age: 12-60 years d) willing to participate in the study and sign the informed consent (by the patient or his/her/partner/guardian) in case of younger than 18 years Exclusion criteria: a) Pregnant or lactating women b) Duration of lesions more than 3 months c) Number of lesions more than 5 d) Ulcer size greater than 5 cm in the largest diameter e) History of full course of standard treatment (antimonials) f) History of allergy to meglumine antimoniate or silver g) Serious systemic illnesses as judged by the physician h) Participation in any drug trial in the last 60 days i) Indication for administration of systemic treatment with meglumine antimoniate j) Presence of secondary bacterial infection of the lesion according to clinical appearance of the lesion

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete healing. Timepoint: at 6 weeks after initiation of the intrvention(s). Method of measurement: Lesions' assessment of healing by measuring the size of induration and ulcer.

Secondary Outcome Measures

Name	Time	Method
Complete healing. Timepoint: at 6 months after initiation of the intervention(s). Method of measurement: Lesions' assessment of healing by measuring the size of induration and ulcer.;Adverse Effects. Timepoint: Recorded at each follow-up visit. Method of measurement: Taking medical history and performing physical examination.