Clinical Trial: Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Brief Summary: The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).

Detailed Summary:

A total of 20 subjects are to be included in 1 site in Germany.

Methodology:

Subjects will receive the following treatments on the right or left toenails:

  • Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot.
  • Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.

Sponsor: Galderma

Current Primary Outcome: % "in label" adherent subjects [ Time Frame: Week 12 ]

Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks)


Original Primary Outcome: Same as current

Current Secondary Outcome: % subjects satisfied to very satisfied with each study treatment at week 12 [ Time Frame: Week 12 ]

Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12


Original Secondary Outcome: Same as current

Information By: Galderma

Dates:
Date Received: November 20, 2015
Date Started: September 2015
Date Completion:
Last Updated: July 26, 2016
Last Verified: July 2016