Efficacy and tolerability of a biomineral formulation for treatment of onychoschizia: a randomized trial

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.