Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Leishmaniasis, Cutaneous Clinical Trial

Official title:

Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096457
• Other study ID #: ABF-BO-2016-102
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 15, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: July 2018
• Source: Fundacion Nacional de Dermatologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2018
• Est. primary completion date: March 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leishmania Braziliensis Complex
• Leishmaniasis
• Leishmaniasis, American
• Leishmaniasis, Cutaneous
• Leishmaniasis; American, Cutaneous

Intervention

Drug:
• Paromomycin Sulfate
topical application 2 times a day during 20 days
• Pentamidine Isethionate
3 Intralesional injections at days 1,3 and 5

Other:
• Placebo
topical application 2 times a day during 20 days

Locations

Country	Name	City	State
Bolivia	Hospital Dermatologico de Jorochito	Jorochito	SC
Bolivia	Hospital Local Palos Blancos	Palos Blancos	La Paz

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Nacional de Dermatologia

Country where clinical trial is conducted

Bolivia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Lesion size	change of lesion area at 6 months after treatment compared to baseline	6 months
Secondary	Number of participants with treated-related adverse events	Adverse events will measured according to CTCAE 4.03	1 month