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
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: 20 May 2016
Trial Phase: Phase 4
clinical Trials Gov ID: NCT02679911
Trial status: Active