Development of an ointment for the treatment of cutaneous Leishmaniasis
- Conditions
- cutaneous leishmaniasis
- Registration Number
- RBR-249zxxh
- Lead Sponsor
- niversidade Federal do Amazonas - UFAM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Age between 18 and 70 years; both genders; Individuals considered healthy after initial clinical and laboratory evaluation; Agreement and voluntary signature of the free and informed consent form
Individuals who present alterations in the pre-treatment clinical and/or laboratory assessment; History of visceral leishmaniasis or American cutaneous leishmaniasis; Liver or kidney dysfunction, diabetes or heart disease; Allergy to the experimental treatment; Pregnant and lactating women; Alcoholics, smokers or those using medication; Patients with chronic diseases and/or infectious diseases such as tuberculosis, leprosy, human immunodeficiency virus, visceral leishmaniasis or American cutaneous leishmaniasis, among others; Patients with a medical history of visceral leishmaniasis or American cutaneous leishmaniasis; Inability or refusal to sign the informed consent form or inability to comply with the experimental protocol
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected with this project that the pharmaceutical compound in topical formulation with the purpose of combating the Leishmaniasis parasite is safe, with no adverse effect in phase 1 tests, thus being able to proceed to phase 2 tests.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are not expected