IRCT138707201166N2CompletedPhase 2
Assessment of the efficacy of the combination of a silver-containing dressing with intralesional meglumine antimoniate injections in comparison with a combination of an inert dressing and intralesional meglumine antimoniate injections and intralesional meglumine antimoniate injections alone in the treatment of cutaneous leishmaniasis due to Leishmania major: A randomized assessor-blind controlled clinical trial
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 210
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 12 years to 60 years (—)
- Sex
- All
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
Investigators
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