Trial reportPLoS neglected tropical diseases2018
A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia.
Trial report in PLoS neglected tropical diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01845727 (Safety, Pharmacokinetics, and Efficacy of Topical 3% Amphotericin B Cream for the Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety, Pharmacokinetics, and Efficacy of Topical 3% Amphotericin B Cream for the Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review.PLoS neglected tropical diseases · 2024Pooled it
- Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020Pooled it
- A phase Ib/II clinical study to evaluate the safety and efficacy of topical Arnica tincture to treat non-complicated cutaneous leishmaniasis in Colombia.PLoS neglected tropical diseases · 2025Trial
- Immunochemotherapy with Amphotericin B and HisAK70 Vaccine for Cutaneous Leishmaniosis.International journal of molecular sciences · 2026Article
- The Safety and Efficacy of an Immunomodulator Garlic-Based Cream (LeishG1) for Treating Uncomplicated Cutaneous Leishmaniasis: A Single-Blind, Multi-Center Study.Health science reports · 2025Article
- In Vitro Efficacy and Toxicity Assessment of an Amphotericin B Gel for the Treatment of Cutaneous Leishmaniasis.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Zinc nanoparticles coated with peppermint (Journal of parasitic diseases : official organ of the Indian Society for Parasitology · 2025Article
- Biocompatibility and Effectiveness of Amphotericin B-Loaded Metal-Organic Structures (AmB-ZIF-8) as Dermal Drug Transporters in Experimental Cutaneous Leishmaniasis.Journal of experimental pharmacology · 2025Article
- Cutaneous leishmaniasis: epidemiology, treatment access and translational challenges of topical therapies.Frontiers in microbiology · 2025Review
- Rising pharmaceutical innovation in the Global South: a landscape study.Journal of pharmaceutical policy and practice · 2023Article
- Liposomal Amphotericin B for Treatment of Leishmaniasis: From the Identification of Critical Physicochemical Attributes to the Design of Effective Topical and Oral Formulations.Pharmaceutics · 2022Review
- Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments.American journal of clinical dermatology · 2022Review
- Review of potential medical treatments for middle ear cholesteatoma.Cell communication and signaling : CCS · 2022Review
- Efficacy of topical Miltefosine formulations in an experimental model of cutaneous leishmaniasis.Drug delivery and translational research · 2022Article
- Efficacy of topical risedronate and risedronate - Eudragit E complex in a model of cutaneous leishmaniasis induced byHeliyon · 2021Article
- Amphotericin B-loaded deformable lipid vesicles for topical treatment of cutaneous leishmaniasis skin lesions.Drug delivery and translational research · 2021Article
- Therapeutic advances in the topical treatment of cutaneous leishmaniasis: A review.PLoS neglected tropical diseases · 2021Review
- Pharmacokinetics and pharmacodynamics in the treatment of cutaneous leishmaniasis - challenges and opportunities.RSC medicinal chemistry · 2021Review
- Nanoemulsified Butenafine for Enhanced Performance against Experimental Cutaneous Leishmaniasis.Journal of immunology research · 2021Article
- Efficacy of histamine H1 receptor antagonists azelastine and fexofenadine against cutaneous Leishmania major infection.PLoS neglected tropical diseases · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPentavalent antimonials (Sb5) are the first-line drugs for treating cutaneous leishmaniasis in Colombia; however, given problems with toxicity, compliance, availability, and cost, it is imperative to look for better therapeutic options. Intravenous amphotericin B (AmB) has been used extensively to treat visceral leishmaniasis; however, evidence on its topical use for cutaneous leishmaniasis is limited. Anfoleish is a topical formulation based on 3% AmB, which was developed following GMP standards by HUMAX and PECET. Anfoleish was shown to be safe and efficacious in animal model and in an open label study in CL patients. Hereafter we show the results of the first controlled and randomized study assessing the safety and efficacy of Anfoleish administered topically, two or three times per day for 28 days, for the treatment of non-complicated cutaneous leishmaniasis in Colombia.
methodsAn open-label, randomized, non-comparative phase Ib/II clinical trial was performed. Adult volunteers with a parasitologically confirmed diagnosis of cutaneous leishmaniasis were randomly allocated to receive Anfoleish cream either 3 (TID group) or 2 (BID group) times per day for 4 weeks.
results80 out of 105 subjects screened were included in the study. In intention to treat analysis, final cure was observed in 13 (32.5%) out of 40 subjects (IC 95% = 20.1-48) and in 12 (30%) out of 40 subjects (IC 95% = 18.1-45.5) in the BID and TID group respectively. In the per protocol analysis, cure rates were 39.4% (n = 13) (IC 95% = 24.7-56.3) and 35.3% (n = 12) (IC 95% = 21.5-52.1) in the BID and TID groups respectively. Anfoleish proved to be safe, and the few adverse events reported were local, around the area of application of the cream, and of mild intensity.
conclusionAnfoleish showed to be a safe and well-tolerated intervention. Its efficacy results however do not support at this time continuing with its clinical development or recommending it for the treatment of CL. Additional, studies to improve its current formulation are needed before thinking in conducting additional studies in patients.
trial registrationRegistered in clinicaltrials.gov NCT01845727.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.