Efficacy and tolerability of a biomineral formulation for treatment of onychoschizia: a randomized trial
Received 10 October 2018
Accepted for publication 15 February 2019
Published 13 May 2019 Volume 2019:12 Pages 355—362
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Jeffrey Weinberg
Adele Sparavigna, Beatrice Tenconi, Laura La Penna
DERMING, Clinical Research and Bioengineering Institute, Milan, Italy
Purpose: Onychoschizia causes lamellar splitting of the nail plate. It is a common problem seen by dermatologists therefore, an effective treatment is needed. The aim of this study was to evaluate the efficacy and tolerability of a biomineral formulation (Biomineral Unghie) applied topically, and/or as an oral supplement, in subjects with onychoschizia.
Patients and methods: This single center, randomized, parallel-group, open-label study was conducted between March 2017 and June 2017. Fifty non-menopausal females aged 18 years or over with onychoschizia were randomized (1:1:1) into three treatment arms to receive either topical and/or oral biomineral formulation for 3 months. Subjects were randomized using a predefined randomization list. The primary objective was to determine the efficacy of the biomineral formulation.
Results: Forty-eight subjects were included in the clinical assessment of nail hardness with 16 subjects in each treatment arm. After 3 months, fingernail hardness improved across the topical, oral and combined treatment arms compared with baseline: 40% (P<0.01 versus untreated hand), 43% and 50% (P<0.05 for both), respectively. Image analysis of the nail was carried out on 33 subjects with longitudinal and/or transversal fingernail grooves. Nail roughness was significantly reduced across all arms after 3 months compared with baseline (topical [n=11], −12%; oral supplement [n=10], −18%; combined topical/oral [n=12], −15%; all P<0.05). Subjects considered fingernail resistance, smoothness, glossiness, growth and general nail condition to be improved across all treatment arms. No adverse events were reported.
Conclusion: The biomineral formulation was effective in improving nail condition in subjects with onychoschizia after 3 months.
Keywords: nail fragility, nail plate, lamellar splitting, supplements
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