Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (LOOP)
Primary Purpose
Foot Dermatoses
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Loceryl NL
Ciclopirox NL
Sponsored by
About this trial
This is an interventional treatment trial for Foot Dermatoses focused on measuring Onychomycosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Loceryl NL
Ciclopirox NL
Arm Description
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
Outcomes
Primary Outcome Measures
Percent of "in Label" Adherent Subjects
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
Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12
Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02679911
Brief Title
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Acronym
LOOP
Official Title
Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Dermatoses
Keywords
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Intra-individual study
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loceryl NL
Arm Type
Experimental
Arm Description
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
Arm Title
Ciclopirox NL
Arm Type
Active Comparator
Arm Description
Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
Intervention Type
Drug
Intervention Name(s)
Loceryl NL
Other Intervention Name(s)
Loceryl Nail Lacquer
Intervention Description
Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
Intervention Type
Drug
Intervention Name(s)
Ciclopirox NL
Other Intervention Name(s)
Ciclopirox Nail Lacquer
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent of "in Label" Adherent Subjects
Description
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)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12
Description
Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Schaller
Organizational Affiliation
Universitäts-Hautklinik
Official's Role
Principal Investigator
Facility Information:
City
Tübingen
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
We'll reach out to this number within 24 hrs