Foot Dermatoses Clinical Trial
— OPENOfficial title:
Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%
Verified date | September 2016 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).
Status | Completed |
Enrollment | 22 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit, - Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm, - Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet, - Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline Exclusion Criteria: - Subjects with matrix involvement on the great toenails, - Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study - Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure), - Known immunodeficiency, radiation therapy, immune suppressive drugs, |
Country | Name | City | State |
---|---|---|---|
Iceland | Principal Investigator | Reykjavik |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
Iceland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % adherent subjects with applications | Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole) | Week 7 | |
Primary | % adherent subjects with nail preparation | Percent of subjects having prepared affected toenails as instructed for each product before applications:
For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab For Urea: Soak toenails in warm water and remove soften infected toenails plates For Bifonazole: Clean and dry thoroughly affected toenails |
Week 7 | |
Primary | % Subjects satisfied to very satisfied with each study treatment at week 7 | Percent of subjects satisfied to very satisfied with each study treatment at week 7 | Week 7 |
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