Uncomplicated Cutaneous Leishmaniasis Skin and Connective Tissue Diseases
Conditions
Interventions
Local thermotherapy or heat therapy
Sponsors
Armauer Hansen Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Males and females, aged =18 and =60 years old. · Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods: 1) Microscopic identification of amastigotes in stained lesion tissue, or 2) Demonstration of Leishmania by Polymerase Chain Reaction (PCR), or 3) Positive by NNN culture for promastigotes. Patient who has a lesion that satisfies the following criteria: - Lesion size less than or equal to 4 cm (longest diameter). - Not located on the ear, close to mucosal membranes, or in a location that in the opinion of the Principal Investigator (PI) is difficult to apply either intervention. - Patient with less than or equal to 4 CL lesions. - Duration of lesion less than 6 months by patient history. · Patient able to give written informed consent. In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
Exclusion criteria
Exclusion criteria: •Females with a positive urine pregnancy test at screening and/or who do not agree to take contraception until end of treatment. •Prior topical treatment failure (including SSG-IL and/or cryotherapy) •Receiving a conventional treatment or traditional remedy against CL within 2 months of enrolment into the study •Any condition that prevents the patient from following the study treatment and/or the follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. The proportion of adverse events by treatment group, as well as its frequency, severity, causality with each study drug and seriousness, b. The proportion of initial clinical/ late responders and final cure in each regimen (TT or IL-SSG) measured at Day 90/ Day 105 and Day 180 after onset of treatment respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Identify variation in isolates from different geographic and clinical types and associate with pathology and treatment response. b. Identify markers for potential point of care diagnosis/prognosis and epidemiological application. c. Assess the prevalence and impact of LRV on clinical phenotype and treatment outcomes. d. Document the quality of life from patients and health care provider perspective. | — |
Countries
Ethiopia
Contacts
Public ContactAdamu Bayissa
Clinical Coordinator
Outcome results
None listed