CompletedPhase 1/2

Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.

Brazil20 participantsStarted 2019-01-17

Plain-language summary

This project is composed of a phase I study with the purpose of evaluating adverse reactions and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29, with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of cutaneous leishmaniasis.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days. Exclusion Criteria: * Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.

What they're measuring

Cure

Timeframe: 90 days

Trial details

NCT IDNCT06000514

SponsorHospital Universitário Professor Edgard Santos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-06

View on ClinicalTrials.gov More Cutaneous Leishmaniasis, American trials