Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

Hospital Universitário Professor Edgard Santos

Status and phase: Completed; Phase 2

Conditions: Leishmaniasis, Cutaneous; Leishmaniasis; American; Leishmaniasis

Treatments: Drug: Immucillin DI4G; Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT03294161

Immucillin DI4GTrial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Immucillin DI4G

Experimental group

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 .

Treatment:

Drug: Immucillin DI4G

Meglumine Antimoniate

Active Comparator group

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.

Treatment:

Drug: Meglumine antimoniate