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Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

Primary Purpose

Leishmaniasis, Leishmaniasis, Cutaneous, Leishmaniasis; American

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Immucillin DI4G
Meglumine antimoniate
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leishmaniasis focused on measuring Meglumine antimoniate, L.Braziliensis, Immunotherapy, Immucillin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
  • Number of lesions: 1 to 3 ulcerative lesions.
  • Lesion´s diameter: 1 to 5 cm.
  • Disease duration: up to three months.

Exclusion Criteria:

  • Aspartate aminotransferase, alanine aminotransferase >3 times upper limit of normal range
  • Serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range
  • Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
  • Immunodeficiency or antibody to HIV
  • Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
  • Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
  • Negative parasitology (aspirate/biopsy/PCR) or negative Montenegro test
  • Any history of prior anti-leishmania therapy
  • Any condition which compromises ability to comply with the study procedures
  • Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
  • Anticipated non-availability for study visits/procedure

Sites / Locations

  • Corte de Pedra Health Post

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immucillin DI4G

Meglumine Antimoniate

Arm Description

Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + Immucillin DI4G 2% by topical use once a day at the ulcer for 20 days .

Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + placebo for topical use once a day at the ulcer for 20 days.

Outcomes

Primary Outcome Measures

Cure rate or complete cicatrization of the ulcer.
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.

Secondary Outcome Measures

Initial cure rate or complete cicatrization of the ulcer.
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.

Full Information

First Posted
September 22, 2017
Last Updated
September 25, 2017
Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia, Pontificia Universidade Católica do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03294161
Brief Title
Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis
Official Title
Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase as an Adjunct in Cutaneous Leishmaniasis Therapy: a Randomized and Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia, Pontificia Universidade Católica do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous Leishmaniasis in Bahia, Brazil.
Detailed Description
The treatment of cutaneous leishmaniasis caused by L. braziliensis in Brazil with pentavalent antimony is associated with a high rate of failure, reaching up to 45% of cases. Additionally, pentavalent antimony is only administered by parenteral route with important toxicity and ulcer lesion healing takes a long time, from 2 to 3 months. So, this randomized and controlled clinical trial was designed to compare the efficacy and safety of standard antimonial (20mg/day /kg for 20 days) associated with Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use versus standard antimonial (20mg/kg/day for 20 days) associated with placebo for topical use in the treatment of Cutaneous Leishmaniasis and Early Cutaneous Leishmaniasis caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia, Brazil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Leishmaniasis, Cutaneous, Leishmaniasis; American
Keywords
Meglumine antimoniate, L.Braziliensis, Immunotherapy, Immucillin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immucillin DI4G
Arm Type
Experimental
Arm Description
Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + Immucillin DI4G 2% by topical use once a day at the ulcer for 20 days .
Arm Title
Meglumine Antimoniate
Arm Type
Active Comparator
Arm Description
Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + placebo for topical use once a day at the ulcer for 20 days.
Intervention Type
Drug
Intervention Name(s)
Immucillin DI4G
Other Intervention Name(s)
Fourth-generation Immucillin Derivative
Intervention Description
Immucillin DI4G was administered by topical use at 2% concentration once a day for 20 days associated with Meglumine antimoniate administered by intravenous route at a dosage of 20mg/kg/day, during 20 days.
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Other Intervention Name(s)
Glucantime
Intervention Description
Placebo for topical use once a day at the ulcer for 20 days associated with Meglumine antimoniate administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
Primary Outcome Measure Information:
Title
Cure rate or complete cicatrization of the ulcer.
Description
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Initial cure rate or complete cicatrization of the ulcer.
Description
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
Time Frame
2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). Number of lesions: 1 to 3 ulcerative lesions. Lesion´s diameter: 1 to 5 cm. Disease duration: up to three months. Exclusion Criteria: Aspartate aminotransferase, alanine aminotransferase >3 times upper limit of normal range Serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) Immunodeficiency or antibody to HIV Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months Negative parasitology (aspirate/biopsy/PCR) or negative Montenegro test Any history of prior anti-leishmania therapy Any condition which compromises ability to comply with the study procedures Lack of ability or willingness to give informed consent (patient and/or parent / legal representative) Anticipated non-availability for study visits/procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar M Carvalho, MD, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo RL Machado, MD, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Chair
Facility Information:
Facility Name
Corte de Pedra Health Post
City
Corte de Pedra
State/Province
Bahia
ZIP/Postal Code
40000
Country
Brazil

12. IPD Sharing Statement

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Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

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