Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

NCT03294161 | Completed Phase 2 DMC

• 1 other identifier: Immucillin DI4GTrial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmaniasis; Leishmaniasis, Cutaneous; Leishmaniasis; American

Keywords

Meglumine antimoniate; L.Braziliensis; Immunotherapy; Immucillin

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after treatment

Secondary Outcomes (1)

• Initial cure rate or complete cicatrization of the ulcer.

  2 months after treatment

Study Arms (2)

Immucillin DI4G

EXPERIMENTAL

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 .

Drug: Immucillin DI4G

Meglumine Antimoniate

ACTIVE COMPARATOR

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.

Drug: Meglumine antimoniate

Interventions

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.

Also known as: Fourth-generation Immucillin Derivative

Immucillin DI4G

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.

Also known as: Glucantime

Meglumine Antimoniate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Federal University of Bahia: collaborator
• Pontificia Universidade Católica do Rio Grande do Sul: collaborator

Study Sites (1)

Corte de Pedra Health Post

Corte de Pedra, Estado de Bahia, 40000, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis; Leishmaniasis, Cutaneous; Leishmaniasis, Mucocutaneous

Interventions

Meglumine Antimoniate

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Edgar M Carvalho, MD, PhD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• Paulo RL Machado, MD, PhD

  Federal University of Bahia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 26, 2017
• Study Start: December 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

BR (1)