OPEN
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%
Sponsor study identifier
interventional
22
1 country
1
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
March 7, 2016
Actual (reported)March 10, 2016
Actual (reported)September 2016
Actual (reported)September 2016
Actual (reported)% 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
% 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
% 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
Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot
On the opposite foot: 1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal) 2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab
Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails
Principal Investigator
Reykjavik, Iceland
Dr Sigurgeirsson
Cutis Ehf (Dermatology Center)
22 participants (actual enrollment reported by the registry).
First Submitted
March 7, 2016
First Posted
March 10, 2016
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis
Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails
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Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
February 17, 2021
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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