Status:
WITHDRAWN
Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis.
Lead Sponsor:
Universidad de Antioquia
Collaborating Sponsors:
INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
Comprehensive Strategy for the Control of Leishmaniasis in Colombia
Conditions:
Leishmaniasis, Cutaneous
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 15 different species of the protozoan parasite Leishmania. The CL usually begins with a papule at the site of the sandfly bite, ...
Detailed Description
Curaleish is a topical formulation in lotion and cream that contains natural extracts (hydroalcoholic and glycolic for lotion and cream, respectively) of the branches (stems and leaves) of the Caesalp...
Eligibility Criteria
Inclusion
- Men and women between 18 - 60 years.
- Patient with confirmed parasitological diagnosis of CL in at least one lesion, performed at least through the following methods: 1) microscopic identification of amastigotes in tissue of the lesion; 2) Leishmania diagnose through PCR; 3) positive culture for promastigotes.
- Patient with a lesion that meets the following criteria:
- . Ulcer or nodule with a maximum size of 4 cm (the largest diameter).
- Not located in the ear, face, near mucous membranes, joints, or in places that, in the opinion of the PI, the study medication is difficult to apply topically.
- Patient with a maximum of four CL lesions.
- The duration of the lesion is less than three months according to the patient's history.
- The patient is able to give written informed consent.
- Patients whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol.
Exclusion
- Patients who meet some of the following criteria must be excluded from the study:
- Women with positive pregnancy test during the screening process, or who are lactating; or women of childbearing age who do not agree to take contraceptives during treatment and until Day 45.
- The subject has a history of significant medical conditions or treatments that may interact negatively or positively with the topical treatment of Leishmaniasis, including any immune compromise condition.
- Within eight weeks (56 days) of beginning the study treatments, having received treatment for Leishmaniasis through any medication, including Glucantime that probably, in the opinion of the principal investigator (PI), might modify the course of the infection by Leishmania.
- Based on physical examinations performed, they have been diagnosed, or a diagnosis of Mucocutaneous Leishmaniasis is suspected.
- Known history or suspected hypersensitivity or idiosyncratic reactions to the study medication.
- Patients who do not wish to attend study appointments or who cannot keep up with follow-up visits for up to 6 months
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04072874
Start Date
January 1 2021
End Date
July 1 2022
Last Update
June 3 2022
Active Locations (1)
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1
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, Colombia, 1226