Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT03829917|
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniasis, American||Drug: Miltefosine and Paromomycin Drug: miltefosine Drug: paromomycin||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 31, 2020|
Experimental: Paromomycin and Miltefosine
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
28 days of miltefosine plus 28 days of Paromomycin cream
Active Comparator: Miltefosine
Miltefosine pills alone [2.5 mg/day [50 mg tid] for 28 days. This group will also receive Aquaphilic-vehicle cream for 28 days
28 days of miltefosine
Active Comparator: Paromomycin
Paromomycin-Aquaphilic cream applied topically once daily for 28 days.
28 days of paromomycin creaam
- Change in Size of cutaneous ulcers [ Time Frame: 2, 3, 4 and 6 months after the begining of therapy. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829917
|Jorochito, SC, Bolivia, 00000|
|Principal Investigator:||JAIME SOTO, MD||Fundación Nacional de Dermatología|