NCT03294161

Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hospital Universitário Professor Edgard Santos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leishmaniasis
• Leishmaniasis, Cutaneous
• Leishmaniasis; American

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2017-09-26
• Last updated: 2017-09-26

Locations

1 site across 1 country: Brazil