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

Overview

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).

Full Title of Study: “Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2016

Detailed Description

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.

Interventions

  • Drug: Loceryl NL
    • Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
  • Drug: Ciclopirox NL
    • Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed

Arms, Groups and Cohorts

  • Experimental: Loceryl NL
    • Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
  • Active Comparator: Ciclopirox NL
    • Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot

Clinical Trial Outcome Measures

Primary Measures

  • Percent of “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)

Secondary Measures

  • Percent of 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

Participating in This Clinical Trial

Inclusion Criteria

  • Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit, – Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm, – Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline, – Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet, Exclusion Criteria:

  • Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy), – Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure), – Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prof. Schaller, Principal Investigator, Universitäts-Hautklinik

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