Clinical Trial: Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish

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

Official Title: Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer 5% Alone in Treatment of Toenail Distal Subungua

Brief Summary:

The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.

The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.


Detailed Summary:

Study center:

A two period study: A total of 50 subjects were to be included in 1 site in Iceland.

Methodology:

  1. Treatment period:

    • Group Loceryl Nail Lacquer+ Cosmetic Varnish:

      • Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
      • Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.

    • Group Loceryl Nail Lacquer alone:

      • Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails.

    At week 12 if no clinical sign of clinical aggravation of Onychomycosis, subjects could enter into a Follow-up period.

  2. Follow-up period:

Subjects were to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).


Sponsor: Galderma

Current Primary Outcome: Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails [ Time Frame: Week 12 ]

Measurement of antifungal activity of Loceryl Nail Lacquer


Original Primary Outcome: Same as current

Current Secondary Outcome: Presence/absence of Dermatophytes in nail samples culture [ Time Frame: Week 12 ]

Original Secondary Outcome: Same as current

Information By: Galderma

Dates:
Date Received: December 8, 2014
Date Started: February 2014
Date Completion:
Last Updated: February 10, 2016
Last Verified: February 2016