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

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).

 

Condition Intervention Phase
Foot Dermatoses Drug: Loceryl Nail Lacquer
Drug: Ciclopirox Nail Lacquer
Phase 4

 

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

 

Resource links provided by NLM:

 

MedlinePlus related topics: Foot Health

Drug Information available for: Ciclopirox Ciclopirox olamine

U.S. FDA Resources 

 

Further study details as provided by Galderma:

 

Primary Outcome Measures:

  • % "in label" adherent subjects [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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 Outcome Measures:

  • % subjects satisfied to very satisfied with each study treatment at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

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

 

Estimated Enrollment: 20
Study Start Date: September 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Date of article/Start date of trial: 

Friday, May 20, 2016

Trial phase: 

Phase 4

ClinicalTrials.gov ID: 

NCT02679911

Trial status: 

Active
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