CompletedPhase 2/3

Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis

Bolivia120 participantsStarted 2019-02-01

Plain-language summary

Cure rate for L braziliensis bolivian CL has been 70%-80% for standard systemic and local monotherapies. It would benefit patients if cure rates could be consistently \>90%, so testing a combination of two treatments is proposed. The most attractive systemic therapy is the only oral agent, miltefosine during 28 days, and the most attractive local therapy is application of Paromomycin cream for 28 days.

Who can participate

Age range12 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 and exlusion Criteria: * Gender: Male or female * Age: \>12 yrs of age * Presentation: 1-to-2 ulcerative lesions, each \< 30 mm in largest diameter and with a total lesion area \<900 mm2. * Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion. * Previous treatment for leishmaniasis: * No specific or putatively specific therapy (Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol) in the last 3 months * Other diseases: No concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.

What they're measuring

Change in Size of cutaneous ulcers

Timeframe: 2, 3, 4 and 6 months after the begining of therapy.

Trial details

NCT IDNCT03829917

SponsorFundacion Nacional de Dermatologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-01

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