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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
Sponsor:
Collaborators:
Hospital Dermatológico de Jorochito
Ministerio de Salud de Bolivia, Programa Nacional de Leishmaniasis
Alfred Berman Foundation
Information provided by (Responsible Party):
Fundacion Nacional de Dermatologia

Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis, American Drug: Miltefosine and Paromomycin Drug: miltefosine Drug: paromomycin Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
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
Drug: miltefosine
28 days of miltefosine

Active Comparator: Paromomycin
Paromomycin-Aquaphilic cream applied topically once daily for 28 days.
Drug: paromomycin
28 days of paromomycin creaam




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Bolivia
Hopital, Dermatologico
Jorochito, SC, Bolivia, 00000
Sponsors and Collaborators
Fundacion Nacional de Dermatologia
Hospital Dermatológico de Jorochito
Ministerio de Salud de Bolivia, Programa Nacional de Leishmaniasis
Alfred Berman Foundation
Investigators
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Principal Investigator: JAIME SOTO, MD Fundación Nacional de Dermatología
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Responsible Party: Fundacion Nacional de Dermatologia
ClinicalTrials.gov Identifier: NCT03829917    
Other Study ID Numbers: AB-2018-02
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Miltefosine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
Antineoplastic Agents