Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

February 28, 2029

Conditions
Leishmaniasis, Cutaneous
Interventions
DRUG

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.

DRUG

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."

Trial Locations (1)

0004

Grupo de Investigación Clínica PECET (GIC-PECET), Medellín

All Listed Sponsors
collaborator

INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)

UNKNOWN

lead

Universidad de Antioquia

OTHER