Status:
COMPLETED
Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed study encompasses a two-step approach. The first aiming to determine the safety of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in subjects with un-...
Eligibility Criteria
Inclusion
- Subject with a confirmed infection due to L. braziliensis by polymerase chain reaction assay
- Subject has a lesion that satisfies the following criteria:
- ulcerative in character
- ulcer size equal or more than 0.5 cm and 3 cm (Longest diameter)
- not located on the ear, face, close to mucosal membranes, joints or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
- Subject with up to 3 lesions.
- Duration of lesion less than 3 months by patient history
- Subject able to give written informed consent and that the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Exclusion
- Female with a positive serum pregnancy test at screening or who is breast feeding, lactating or female at fertile age who does not agree to take appropriate contraception during treatment period up to Day 45.
- History of clinically significant medical problems or treatment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
- Within 8 weeks (56 days) of starting study treatments, received treatment for leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection
- Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
- History of known or suspected hypersensitivity or idiosyncratic reactions to amphotericin
- Has laboratory values at screening as follow: Haemoglobin below 10 grams, Serum creatinine above normal level, alanine aminotransferase and or aspartate aminotransferase 3 times above normal range
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01845727
Start Date
February 1 2014
End Date
July 1 2016
Last Update
July 26 2016
Active Locations (1)
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1
Programa de Estudios y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia
Medellín, Colombia