- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096457
Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).
After treatment, all patients will be followed for 1, 3, and 6 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
La Paz
-
Palos Blancos, La Paz, Bolivia, 00000
- Hospital Local Palos Blancos
-
-
SC
-
Jorochito, SC, Bolivia
- Hospital Dermatologico de Jorochito
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion 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.
Exclusion Criteria:
- Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months.
- Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1 - Paromomycin cream
40 subjects will be included to receive 15% paromomycin in aquafilm base twice a day during 20 consecutive days.
The lesion will be cleaned , then, a generous amount of the study drug (an amount sufficient to cover the area of the ulcer and the lesion border) will be applied to the lesion and rubbed into the ulcer using a gloved finger by a member of the clinical study staff.
After application of the study drug, the patient will be observed for 15 minutes for signs of adverse events.
If there are no signs of local toxicity, the area of the ulcer will be covered with extra study drug.
For Days 2-20, the study drug will be applied and the lesion covered with a sterile gauze and tape dressing as on Day 1.
|
topical application 2 times a day during 20 days
|
ACTIVE_COMPARATOR: Group 2. Local Injectable Pentamidine
20 subjects will be included to receive IL pentamidine [Pentacarinat® Sanofi-Aventis: 30 mg/ml] will administered at a dose of 120 ug (4 ul) per mm2 of lesion area 3 times (on days 1, 3, and 5) as per our previous experience. A small button of Xylocaine® will be applied by means of a thin needle at the four cardinal points of the lesion and then a small gauge (23g) needle will introduce the drug in each cardinal point. The needle will be moved in all directions to infiltrate of whole lesion and surrounding infiltrated area. |
3 Intralesional injections at days 1,3 and 5
|
PLACEBO_COMPARATOR: Group 3. Vehicle control
10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1
|
topical application 2 times a day during 20 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Lesion size
Time Frame: 6 months
|
change of lesion area at 6 months after treatment compared to baseline
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treated-related adverse events
Time Frame: 1 month
|
Adverse events will measured according to CTCAE 4.03
|
1 month
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Oliveira-Neto MP, Schubach A, Mattos M, da Costa SC, Pirmez C. Intralesional therapy of American cutaneous leishmaniasis with pentavalent antimony in Rio de Janeiro, Brazil--an area of Leishmania (V.) braziliensis transmission. Int J Dermatol. 1997 Jun;36(6):463-8. doi: 10.1046/j.1365-4362.1997.00188.x.
- Vasconcellos Ede C, Pimentel MI, Schubach Ade O, de Oliveira Rde V, Azeredo-Coutinho RB, Silva Fda C, Salgueiro Mde M, Moreira JS, Madeira Mde F, Baptista C, Valete-Rosalino CM. Intralesional meglumine antimoniate for treatment of cutaneous leishmaniasis patients with contraindication to systemic therapy from Rio de Janeiro (2000 to 2006). Am J Trop Med Hyg. 2012 Aug;87(2):257-60. doi: 10.4269/ajtmh.2012.11-0612.
- Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.
- Soto J, Paz D, Rivero D, Soto P, Quispe J, Toledo J, Berman J. Intralesional Pentamidine: A Novel Therapy for Single Lesions of Bolivian Cutaneous Leishmaniasis. Am J Trop Med Hyg. 2016 Apr;94(4):852-6. doi: 10.4269/ajtmh.15-0640. Epub 2016 Feb 22.
- Ben Salah A, Ben Messaoud N, Guedri E, Zaatour A, Ben Alaya N, Bettaieb J, Gharbi A, Belhadj Hamida N, Boukthir A, Chlif S, Abdelhamid K, El Ahmadi Z, Louzir H, Mokni M, Morizot G, Buffet P, Smith PL, Kopydlowski KM, Kreishman-Deitrick M, Smith KS, Nielsen CJ, Ullman DR, Norwood JA, Thorne GD, McCarthy WF, Adams RC, Rice RM, Tang D, Berman J, Ransom J, Magill AJ, Grogl M. Topical paromomycin with or without gentamicin for cutaneous leishmaniasis. N Engl J Med. 2013 Feb 7;368(6):524-32. doi: 10.1056/NEJMoa1202657.
- Soto J, Soto P, Ajata A, Luque C, Tintaya C, Paz D, Rivero D, Berman J. Topical 15% Paromomycin-Aquaphilic for Bolivian Leishmania braziliensis Cutaneous Leishmaniasis: A Randomized, Placebo-controlled Trial. Clin Infect Dis. 2019 Feb 15;68(5):844-849. doi: 10.1093/cid/ciy619.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Cutaneous
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Trypanocidal Agents
- Paromomycin
- Pentamidine
Other Study ID Numbers
- ABF-BO-2016-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leishmaniasis, Cutaneous
-
Medecins Sans Frontieres, NetherlandsUnknownOld World Cutaneous Leishmaniasis
-
Hospital Universitário Professor Edgard SantosOswaldo Cruz Foundation; Conselho Nacional de Desenvolvimento Científico e...CompletedCutaneous Leishmaniasis, AmericanBrazil
-
Fundacion Nacional de DermatologiaHospital Dermatologico de Jorochito; Ministerio de Salud de Bolivia, Programa... and other collaboratorsCompletedCutaneous Leishmaniasis, AmericanBolivia
-
Centro Internacional de Entrenamiento e Investigaciones...University of TexasCompletedCutaneous Leishmaniasis (Diagnosis)Colombia
-
Drugs for Neglected DiseasesWellcome Trust grant 212346/Z/18/Z - 21st Century Treatments for Sustainable...CompletedVisceral Leishmaniasis | Cutaneous LeishmaniasesUnited Kingdom
-
Knight Therapeutics (USA) IncCompletedCutaneous Leishmaniasis | Mucosal LeishmaniasisUnited States
-
Hospital Universitário Professor Edgard SantosInstituto Gonçalo Muniz FIOCRUZ BANot yet recruitingCutaneous Leishmaniasis, AmericanBrazil
-
Centro Internacional de Entrenamiento e Investigaciones...Universidad IcesiCompletedCutaneous Leishmaniasis, AmericanColombia
-
University of BrasiliaCompletedLocalized Cutaneous LeishmaniasisBrazil
-
U.S. Army Medical Research and Development CommandCompletedOld World Cutaneous LeishmaniasisTunisia
Clinical Trials on Paromomycin Sulfate
-
KU LeuvenUnknownConcentration-Time Profiles in Stomach & Intestine.Belgium
-
PATHCompletedVisceral LeishmaniasisIndia
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | CryptosporidiosisUnited States, Puerto Rico
-
University of LeipzigUnknownAnastomotic Leak | Surgical Site InfectionGermany
-
PATHInternational Centre for Diarrhoeal Disease Research, Bangladesh; Shaheed Suhrawardy... and other collaboratorsCompletedVisceral LeishmaniasisBangladesh
-
PATHWorld Health OrganizationCompletedVisceral LeishmaniasisIndia
-
U.S. Army Medical Research and Development CommandCompleted
-
Banaras Hindu UniversityDrugs for Neglected Diseases; Rajendra Memorial Research Institute of Medical...Completed
-
National Institute of Allergy and Infectious Diseases...Genetics InstituteTerminatedHIV Infections | CryptosporidiosisUnited States
-
Drugs for Neglected DiseasesMakerere University; The Netherlands Cancer Institute; Kenya Medical Research... and other collaboratorsCompletedVisceral LeishmaniasisEthiopia, Kenya, Sudan, Uganda