Conflict of interest None declared.
Nail penetration and predicted mycological efficacy of an innovative hydrosoluble ciclopirox nail lacquer vs. a standard amorolfine lacquer in healthy subjects
Article first published online: 26 MAR 2012
© 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology
Journal of the European Academy of Dermatology and Venereology
Volume 27, Issue 2, pages e153–e158, February 2013
How to Cite
Monti, D., Herranz, U., Dal Bo, L. and Subissi, A. (2013), Nail penetration and predicted mycological efficacy of an innovative hydrosoluble ciclopirox nail lacquer vs. a standard amorolfine lacquer in healthy subjects. Journal of the European Academy of Dermatology and Venereology, 27: e153–e158. doi: 10.1111/j.1468-3083.2012.04529.x
Funding sources This study was supported by Polichem S.A. (Switzerland).
- Issue published online: 22 JAN 2013
- Article first published online: 26 MAR 2012
- Received: 2 November 2011; Accepted: 27 February 2012
Background In a previous study a new hydrosoluble nail lacquer (P-3051) containing 8% ciclopirox (CPX) showed higher nail penetration compared to a water-insoluble 5% amorolfine (MRF) lacquer. To our knowledge, in vivo human data on a similar topic are not available.
Objectives To compare fingernail penetration of P-3051 with that of MRF reference in humans and to evaluate their predicted efficacy against Trichophyton rubrum and Candida parapsilosis.
Methods Single centre, randomized, multiple dose, open label, within subjects study. Test and reference were self-applied to all fingernails of either hand for 28 days. At baseline and after 15 and 25 days, the nail free edge was collected for analysis. Efficiency coefficients were calculated for T. rubrum and C. parapsilosis as ratios of nail concentration/minimum inhibitory concentration. The coefficients were classified as very high, high or poor.
Results Nail concentrations after 15 days were 2.82 ± 0.58 μg/mg for CPX and 0.64 ± 0.11 μg/mg for MRF. At day 25 there was a non-significant decline (1.85 ± 0.31 μg/mg, P = 0.077) for CPX and a highly significant (0.13 ± 0.03 μg/mg, P = 0.0002) 80% decline for MRF. Efficiency coefficients were very high/high in all subjects treated with P-3051 against both T. rubrum and C. parapsilosis; they were significantly lower for MRF reference against both pathogens at both observation points.
Conclusions P-3051 exhibited better penetration and higher predicted efficacy after in vivo multiple application to human fingernails when compared to MRF reference. These in vivo data are in good agreement with our previous in vitro study.