Journal of Clinical & Experimental Dermatology Research
Open Access

Abstract

Efficacy and Tolerability of a Nail Lacquer Formulation with Urea 20%, Keratinase, and Hydroxypinacolone Retinoate in Subjects with Onychogryphosis/Onychodystrophy: A Multicentre, Prospective, Assessor-Blinded, Study on 519 Subjects (the "uko" Trial)

Francesca Colombo, Massimo Milani*, The UKO Trial Investigators Group, Andrea Giovannini, Antonio Ciciariello, Carlotta Sormani, Carmen Silvia Fiorella, Chiara Calosci, Eleonora Braga, Elisabetta Mapelli, Enrico Giannini, Fabio Marcandalli, Gabriele Tintori, Gemma Pecorari, Giada Sapienza, Giovanni Montesarchio, Giuseppe Zenobio, Ilaria Proietti, Jarno Bortoli, Jeanette Gaido, Karina Schlecht, Luca Martini, Luca Traversone, Luca Antonio Galante, Lucia Scortichini, Marco Spinelli, Marco Adriano Chessa, Maria Ferrillo, Maria Carmela Scalisi, Marianna Breda, Martina Burlando, Massimiliano Galeone, Massimo Iuculano, Matteo Dordoni, Nicolò Rivetti, Pierangela Murabito, Rossana Girotto, Silvia Lovati, Silvia Riva, Simona Berardi and Stefania Bano

Introduction and objectives: Onychogryphosis (OG) is a common disorder of nail plate growth characterized by an opaque, yellow-brown thickening of the nail plate with hyperkeratosis, elongation, and increased curvature. It is most common in older adults. OG can be an important condition because patients may suffer from pain, secondary complications, and cosmetic concerns. A nail lacquer containing urea 20%, keratinase and hydroxypinacolone retinoate (a retinoid molecule) has recently been demonstrated to be effective and well-tolerated in treating Onychodystrophy/Onychogryphosis (OD/OG) and in improving lichen-planus associated nail alterations. Data on a large population of subjects with OD/OG is lacking, so far.

Materials and methods: In a multicentre, real-life study (The “UKO” trail) conducted in thirty-one Italian out-patient dermatology services, five hundred and nineteen subjects (mean age 59 years, 186 men and 333 women) with nonmycotic OD/OG affecting at least one nail of the feet, participated in the trial, after their written informed consent. The subjects were treated with a nail lacquer containing urea 20%, keratinase and a retinoid molecule (hydroxypinacolobne retinoate), one application daily for eight consecutive weeks. The primary endpoints were the evolution of a 3-item (dystrophy, dyschromia and nail thickness) Onychodystrophy Global score (ODGS) using a 3- point scale (from 0 to 2) (maximum ODGS score: 9) from baseline to week eight, evaluated in a blinded fashion using high-definition colour pictures of the affected-nail and the measurement of nail thickness using a calibrate graduated tool. Secondary endpoints were the global physician’s efficacy and tolerability evaluation performed in an open fashion.

Results: At baseline the ODGS scores (mean ± SD) was: 3.5 ± 0.8. After 8 weeks of treatment, the ODGS score was decreased to 1.5 ± 0.6 (-58% in comparison with baseline; p<0.001). After treatment, a complete normalization of nail appearance (i.e an ODGS score of 0) was observed in 46% of subjects. The nail thickness (mean ± SD) at baseline was 4 ± 4.1 mm. The use of the lacquer reduced significantly nail thickness to 2.1 ± 2.8 (a 48% reduction). The nail lacquer was very well tolerated.

Conclusion: In subjects with onychogryphosis/onychodystrophy of toenail, the use of a urea/keratinase/retinoid lacquer is associated with a significant improvement of nail appearance with a relevant reduction in nail thickness.

Published Date: 2023-05-19; Received Date: 2023-04-12