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Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

NCT03294161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-26

No results posted yet for this study

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.

Conditions

  • Leishmaniasis
  • Leishmaniasis, Cutaneous
  • Leishmaniasis; American

Interventions

DRUG

Immucillin DI4G

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.

DRUG

Meglumine antimoniate

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.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Federal University of Bahia

    collaborator OTHER

  • Pontificia Universidade Católica do Rio Grande do Sul

    collaborator OTHER

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Edgar M Carvalho, MD, PhD · Federal University of Bahia

  • Paulo RL Machado, MD, PhD · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-04-30
Completion
2017-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294161 on ClinicalTrials.gov