Trial record 14 of 27 for:    Open Studies | "Leishmaniasis"

Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia (Anfoleish)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Drugs for Neglected Diseases
Sponsor:
Information provided by (Responsible Party):
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT01845727
First received: April 24, 2013
Last updated: June 11, 2014
Last verified: February 2014
  Purpose

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-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in having and indication of the efficacy of the two above mentioned regimens of Topical 3% Amphotericin B Cream

For the first step, 30 subjects will be randomly assigned to receive direct observed treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each group) have been enrolled and completed the 28 day treatment course. An interim analysis of all safety (Adverse Events, including local reactions and lab parameters) and pharmacokinetics collected on subjects who were randomized will be performed by data safety monitoring board. If no serious adverse events (SAEs) related to the study drug are identified on the first 30 subjects by the end of the treatment course, 50 additional subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three or two times per day for 28 days

Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day 180 for final analysis of efficacy.


Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: Topical Amphotericin B at 3%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Pharmacokinetics, and Efficacy of Topical 3% Amphotericin B Cream for the Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia

Resource links provided by NLM:


Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day. [ Time Frame: At the end of treatment (Day 28) ] [ Designated as safety issue: Yes ]

    Local adverse events including erythema/redness, swelling/oedema, and vesicles will be scored according the following criteria:

    Grade 1: Visibly present but not associated with any other symptoms. Grade 2: Visibly present, large area around lesion site, and associated with other symptoms such as itching or pain. Medical intervention may be required.

    Grade 3: Severe symptoms that require medical discontinuation of the study drug.


  • Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Cure is defined as 100% re-epithelialization of the lesion(s) by Day 90.


Secondary Outcome Measures:
  • Determination of Amphotericin B Cmax and Tmax in subjects treated with Anfoleish three or two times per day. [ Time Frame: Day 45 ] [ Designated as safety issue: Yes ]
  • Proportion and severity of laboratory adverse events of Anfoleish or vehicle when applied three or two times per day [ Time Frame: At the end of treatment (Day 28 ] [ Designated as safety issue: Yes ]
    Laboratory adverse events are limited to monitoring serum levels of creatinine, alanine aminotransferase and aspartate aminotransferase.


Other Outcome Measures:
  • Proportion of subjects showing a lesion's relapse by Day 180 [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Relapse defined as a lesion that achieved 100% re-epithelialization by Day 90 that subsequently reopened by Day 180.


Estimated Enrollment: 80
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical Amphotericin B three times per day
Anfoleish applied 3 times per day for 4 weeks (TID group)
Drug: Topical Amphotericin B at 3%
Other Name: Anfoleish
Experimental: Topical Amphotericin B two times per day
Anfoleish applied 2 times per day for 4 weeks (BID group)
Drug: Topical Amphotericin B at 3%
Other Name: Anfoleish

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845727

Contacts
Contact: Ivan Dario Velez, Prof. 57 (4) 219 6501 idvelez@pecet-colombia.org
Contact: Liliana Lopez, MsC 57 (4) 219 6506 lililop14@yahoo.com

Locations
Colombia
Programa de Estudios y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia Recruiting
Medellin, Colombia
Contact: Ivan Velez       idvelez@pecet-colombia.org   
Principal Investigator: Ivan Dario Velez, Prof         
Sponsors and Collaborators
Drugs for Neglected Diseases
  More Information

No publications provided

Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT01845727     History of Changes
Other Study ID Numbers: DNDi-CL-TF001
Study First Received: April 24, 2013
Last Updated: June 11, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Drugs for Neglected Diseases:
Cutaneous leishmaniasis
Topical treatment
Colombia

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014