PLoS neglected tropical diseases · 2025
A phase Ib/II clinical study to evaluate the safety and efficacy of topical Arnica tincture to treat non-complicated cutaneous leishmaniasis in Colombia.
СтатьяКлиническое исследование I фазыКлиническое исследование II фазыРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Robledo Sara M, López Liliana, Quintero Juliana, Tabares Yulied, Garcés Any C, Rios-Echavarria Susana, Soto Esteban, Vélez Iván D, Schmidt Thomas J
Аннотация
BACKGROUND: Cutaneous leishmaniasis (CL) is caused by Leishmania parasites and affects 1.2 million cases annually, mainly in the Americas and the Eastern Mediterranean region. The standard treatment with pentavalent antimonials is often limited by its toxicity, prompting the search for alternative therapies. Arnica montana L. (Asteraceae) is a well-known phytotherapeutic plant with anti-inflammatory properties, traditionally used to treat bruises, sprains, distortions, and inflammation caused by insect bites. In our previous work, Arnica tincture (AT) obtained from the flowers showed excellent in vitro activity against Leishmania and in vivo activity in a golden hamster model of CL. It also demonstrated high skin permeability and retention in the epidermis without systemic circulation, making it a promising option for topical treatment of CL.
METHODS: We conducted a randomized, open-label, phase Ib-II clinical trial. Adults with parasitologically confirmed uncomplicated CL were randomly assigned to receive AT topically, 3 times daily, for either 30 or 45 days. We assessed therapeutic response and monitored safety by recording adverse events at each follow-up visit. All adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
RESULTS: Sixteen subjects were enrolled, with eight assigned to each treatment regimen. Twelve participants completed the 180-day follow-up, all achieved complete lesion healing (100% cure rate). Four participants withdrew their informed consent before or during treatment. The most common adverse events were mild and included erythema, pain, edema, and a burning sensation at the application site. No severe adverse effects were reported.
CONCLUSION: AT showed promising results in treating CL and had a favorable safety profile. Due to the small sample size and lack of comparison with standard therapies, further studies with more robust methodologies are needed to confirm these findings.
TRIAL REGISTRATION: NCT05094908.
METHODS: We conducted a randomized, open-label, phase Ib-II clinical trial. Adults with parasitologically confirmed uncomplicated CL were randomly assigned to receive AT topically, 3 times daily, for either 30 or 45 days. We assessed therapeutic response and monitored safety by recording adverse events at each follow-up visit. All adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
RESULTS: Sixteen subjects were enrolled, with eight assigned to each treatment regimen. Twelve participants completed the 180-day follow-up, all achieved complete lesion healing (100% cure rate). Four participants withdrew their informed consent before or during treatment. The most common adverse events were mild and included erythema, pain, edema, and a burning sensation at the application site. No severe adverse effects were reported.
CONCLUSION: AT showed promising results in treating CL and had a favorable safety profile. Due to the small sample size and lack of comparison with standard therapies, further studies with more robust methodologies are needed to confirm these findings.
TRIAL REGISTRATION: NCT05094908.