CompletedPhase 1/2

Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

Brazil28 participantsStarted 2019-03-01

Plain-language summary

A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).

Who can participate

Age range60 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: * CL clinical diagnosis (presence of an ulcer) * CL confirmed by detection of amastigotes in pathology and/or positive PCR for L. braziliensis in tissue obtained from the ulcer border * Presence of one to a maximum of three ulcers * Ulcer size between 1 and 5 mm * Ulcer evolution of 1 to 6 months Exclusion Criteria: * Previous CL treatment * Renal or hepatic disease * HIV co-infection.

What they're measuring

Total initial cicatrization

Timeframe: 30 to 90 days after the first day of treatment

Trial details

NCT IDNCT06449040

SponsorHospital Universitário Professor Edgard Santos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-01

View on ClinicalTrials.gov More Cutaneous Leishmaniasis, American trials