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

Abstract

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

Acknowledgment

Medical writing assistance in the preparation of this manuscript was provided by Laura Brennan (CircleScience, an Ashfield Company, part of UDG Healthcare plc), and funded by Meda Pharma S.p.A., a Mylan company.

Ethics approval and informed consent

This study was conducted in accordance with the principles of the Declaration of Helsinki and ethical approval was granted by the DERMING independent ethical committee on February 17, 2017. All subjects provided written informed consent.

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author contributions

All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

DERMING, Clinical Research and Bioengineering Institute has received research fees from Meda Pharma S.p.A., a Mylan company. The authors report no other conflicts of interest in this work.