A Phase 2/3 interventional study of Miltefosine and Paromomycin and miltefosine in Cutaneous Leishmaniasis, American, sponsored by Fundacion Nacional de Dermatologia. Completed at 1 site in Bolivia. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Fundacion Nacional de Dermatologia · Phase 2/3, Interventional, and Treatment
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.
Cutaneous leishmaniasis (CL) is endemic in the New World from approximately the US-Mexican border through Central America and the Northern part of South America down to the level of Rio de Janeiro.
L braziliensis CL is perhaps the most important of these diseases, since its natural cure rate is low and it may metastasize, and our group has been evaluating therapies for L braziliensis in Bolivia for some time.
In recent studies at investigator's Bolivian site for the years 2013-2016, the cure rate for L braziliensis CL has been 70%-80% for standard systemic and local therapies. Systemic agents intramuscular pentavalent antimony cured 80% (114 of 143) and oral miltefosine cured 81% (47 of 58). Local injections with pentamidine cured 72% (43 of 60); intralesional antimony cured 70% (21 of 30). In contrast, cryotherapy was ineffective [20% (4 of 20) cured and placebo creams cured 17% (5 of 30) in one report and 10% more recently.
Investigator's have recently evaluated treatment with topical paromomycin cream. Paromomycin-in-Aquaphilic had a cure rate of 77.5% (31 of 40 patients) compared to a cure rate of only 10% (2 of 20 patients) for the Aquaphilic vehicle alone. This remarkably high cure rate, combined with essentially no adverse events (both Paromomycin-Aquaphilic and Aquaphilic vehicle had only grade 1 adverse reactions in 5-10% of patients), makes Paromomycin-Aquaphilic very attractive for Bolivian CL.
It would benefit patients if cure rates could be consistently >90%. Since all the individual therapies, whether systemic, local injections, or local cream, have an approximately 75% cure rate, we propose testing a combination of two treatment. The most attractive systemic therapy is the only oral agent, miltefosine, and the most attractive local therapy is simple application of Paromomycin cream. Thus the present protocol proposes to evaluate the efficacy of miltefosine, 2.5 mg/kg (50 mg tid) for 28 days, plus Paromomycin-Aquaphilic daily for 28 days. The controls will be the two components of this combination used separately: miltefosine alone, Paromomycin-Aquaphilic alone.
21 studies on the registry are indexed under Leishmaniasis, Mucocutaneous; 7 are open to participants now.
This study's enrollment of 120 is above the median of 49 across 16 interventional studies indexed under Leishmaniasis, Mucocutaneous.
Browse Leishmaniasis, Mucocutaneous studies →Fundacion Nacional de Dermatologia is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Inclusion and exlusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Paromomycin-Aquaphilic cream applied topically once daily for 28 days plus oral miltefosine pills 2.5 mg/day \[50 mg tid\] for 28 days.
Drug: Miltefosine and Paromomycin
Miltefosine pills alone \[2.5 mg/day \[50 mg tid\] for 28 days. This group will also receive Aquaphilic-vehicle cream for 28 days
Drug: miltefosine
Paromomycin-Aquaphilic cream applied topically once daily for 28 days.
Drug: paromomycin
Drug pages: Miltefosine · Paromomycin
28 days of miltefosine plus 28 days of Paromomycin cream
28 days of miltefosine
28 days of paromomycin creaam
Change in Size of cutaneous ulcers
Complete healing of all lesions by 6 months after the beginning of therapy. Thus for a patient to be cured: no lesion could enlarge by 50%, relapse, or heal incompletely; and no new Leishmania-positive lesion can have appeared.
Time frame: 2, 3, 4 and 6 months after the begining of therapy.
Plan to share: No
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Miltefosine · Paromomycin
Leishmaniasis, Mucocutaneous →
Fundacion Nacional de Dermatologia