Clinical trial NCT03294161: Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis
Official title: Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase as an Adjunct in Cutaneous Leishmaniasis Therapy: a Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leishmaniasis
Leishmaniasis, Cutaneous
Leishmaniasis; American
Keywords: Meglumine antimoniate
L.Braziliensis
Immunotherapy
Immucillin
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Federal University of Bahia
name: Pontificia Universidade Católica do Rio Grande do Sul
First posted: 2017-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cure rate or complete cicatrization of the ulcer.
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Initial cure rate or complete cicatrization of the ulcer.
timeFrame: 2 months after treatment
Other outcomes:
Locations:
city: Corte de Pedra
country: Brazil
facility: Corte de Pedra Health Post
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Edgar M Carvalho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Bahia
name: Paulo RL Machado, MD, PhD
role: STUDY_CHAIR
References: