Trial reportPLoS neglected tropical diseases2009
First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
Trial report in PLoS neglected tropical diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00257530 (Randomized Double Blind Clinical Trial of Imiquimod), which is not on this map. Cited by 40 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.
Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
Who cites it
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020Pooled it
- Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update.PloS one · 2013Pooled it
- A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.PLoS neglected tropical diseases · 2022Trial
- Intralesional Pentamidine: A Novel Therapy for Single Lesions of Bolivian Cutaneous Leishmaniasis.The American journal of tropical medicine and hygiene · 2016Trial
- Dual immunomodulatory and antileishmanial potential of TLR7/8 agonists againstInfection and immunity · 2025Article
- Leishmaniases: Strategies in treatment development.Parasite (Paris, France) · 2025Review
- Immunotherapeutic Strategies as Potential Treatment Options for Cutaneous Leishmaniasis.Vaccines · 2024Review
- Imiquimod Reverses Chronic Toxoplasmosis-Associated Behavioral and Neurocognitive Anomalies in a Rat Model.Biomedicines · 2024Article
- Epoxy-a-lapachone in nanosystem: a prototype drug for leishmaniasis assessed in the binomial BALB/c - Leishmania (Leishmania) amazonensis.Memorias do Instituto Oswaldo Cruz · 2024Article
- HAS 1: A natural product from soil-isolatedFrontiers in pharmacology · 2022Article
- Toxoplasmosis: Current and Emerging Parasite Druggable Targets.Microorganisms · 2021Review
- Therapeutic advances in the topical treatment of cutaneous leishmaniasis: A review.PLoS neglected tropical diseases · 2021Review
- High Content Analysis of Macrophage-TargetingMicroorganisms · 2021Article
- Imiquimod Targets Toxoplasmosis Through Modulating Host Toll-Like Receptor-MyD88 Signaling.Frontiers in immunology · 2021Article
- Antileishmanial Effects of SyntheticAntimicrobial agents and chemotherapy · 2020Article
- CpG ODN D35 improves the response to abbreviated low-dose pentavalent antimonial treatment in non-human primate model of cutaneous leishmaniasis.PLoS neglected tropical diseases · 2020Article
- Trypanosomatid-Caused Conditions: State of the Art of Therapeutics and Potential Applications of Lipid-Based Nanocarriers.Frontiers in chemistry · 2020Review
- An overview of the treatment of cutaneous leishmaniasis.Faculty reviews · 2020Review
- Route map for the discovery and pre-clinical development of new drugs and treatments for cutaneous leishmaniasis.International journal for parasitology. Drugs and drug resistance · 2019Review
- The combination therapy of meglumine antimoniate and oxiranes (epoxy-α-lapachone and epoxymethyl-lawsone) enhance the leishmanicidal effect in mice infected by Leishmania (Leishmania) amazonensis.International journal for parasitology. Drugs and drug resistance · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrent therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated.
methodsA randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period.
resultsOf the 80 subjects enrolled, 75 completed the study. The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75% (30/40) in the experimental arm and 58% (23/40) in the control arm (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site, where L. braziliensis is the prevalent species. Over the study period, only one adverse event (rash) was recorded, in the experimental arm.
conclusionThe combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant.
trial registrationClinical Trials.gov NCT00257530.
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Registered trials
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.