ArticleDermatology and therapy2018
Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial.
Article in Dermatology and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03382717 (Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Topical and device-based treatments for fungal infections of the toenails.The Cochrane database of systematic reviews · 2020Pooled it
- Comparison of a fractional 2940-nm Er:YAG laser and 5% amorolfine lacquer combination therapy versus a 5% amorolfine lacquer monotherapy for the treatment of onychomycosis: a randomized controlled trial.Lasers in medical science · 2021Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOnychomycosis is a fungal nail infection, frequently caused by dermatophytes, which occurs in 2-14% of Western adults. The present study was set up to evaluate the efficacy and safety of a water-based, peelable nail polish (daily application), which acidifies the nail environment, versus a 5% amorolfine nail lacquer (weekly application) for topical treatment of mild-to-moderate onychomycosis.
methodsOne hundred two adults were randomized in this open, prospective, blinded trial. Clinical efficacy was evaluated at baseline and days 30, 60, 120, and 180, respectively. All patients underwent microbiological testing (at baseline and study end). The primary objective of this trial was the change in the percentage of healthy nail surface at day 180.
resultsThe percentage of healthy surface between baseline and day 180 increased with 11.8% in the test product group and 13.2% in the amorolfine group, which were statistically comparable. Other onychomycosis-related parameters (dystrophy, discolouration, thickening, and healthy aspect, respectively) showed significant (p < 0.05) improvement after 180 days (versus baseline) with both treatments. Clinical performance was further confirmed by the frequency of patients showing onychomycosis improvement or success at the end of the study: 96.0% (test product) versus 79.6% (amorolfine). Microbiological results and improved quality of life confirmed clinical performance. Both treatments were well tolerated and appreciated for their properties and efficacy.
conclusionThe present trial confirmed the clinical performance of daily acidification of the nail, as reflected by (1) a comparable increase of percentage of healthy nail surface following treatment with the test product versus amorolfine, (2) the overall improvement of other onychomycosis-related parameters, (3) user convenience, and (4) absence of side effects. These data indicate that daily application of an aqueous, acetic acid-based, peelable solution can be a convenient, safe, and equally effective alternative for the topical management of onychomycosis.
trial registrationClinicalTrials.gov identifier; NCT03382717
fundingOystershell Laboratories.
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