96
Participants
Start Date
October 31, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
February 28, 2029
Arnica Tincture
Arnika tincture is a topical plant-based preparation legally authorized in Colombia and in the countries of the European community, the product of this study is Arnika tinktur Gehrlicher (5249), manufactured by Gehrlicher Pharmazeutische Extrakte GmbH, Germany. According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of A. montana L, and composed at least 0.04% of sesquiterpene lactones. Arnica tincture will be applied topically by each participant on all lesions until day 30.
Meglumine antimoniate.
"Monotherapy with intralesional pentavalent antimonials is one of the treatments of care used for LC in Colombia and will be used as a comparator for safety evaluation.~Pentavalent antimonials: administered intralesionally. At a dose of 0.008 ml X mm of area of each lesion, maximum 15 ml in total, once a week for 5 weeks."
Grupo de Investigación Clínica PECET (GIC-PECET), Medellín
INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
UNKNOWN
Universidad de Antioquia
OTHER