Skip to main content
OpenTrials
Completed

NCT Number: NCT03294161

Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leishmaniasis Euglenozoa Infections Infections Leishmaniasis, Cutaneous Leishmaniasis, Mucocutaneous Leishmaniasis; American Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Corte de Pedra Health Post

Corte de Pedra, Estado de Bahia, 40000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immucillin DI4G

Drug

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.

Other names: Fourth-generation Immucillin Derivative

Meglumine antimoniate

Drug

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.

Other names: Glucantime

Primary outcomes

  1. Cure rate or complete cicatrization of the ulcer.

    Time frame: 6 months after treatment

    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 outcomes

  1. Initial cure rate or complete cicatrization of the ulcer.

    Time frame: 2 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

Hospital Universitário Professor Edgard Santos

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Federal University of Bahia
  • Pontificia Universidade Católica do Rio Grande do Sul

Registry information

Official study title

Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase as an Adjunct in Cutaneous Leishmaniasis Therapy: a Randomized and Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.