COOL
Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
50
1 country
1
Study Start
February 2014
Actual (reported)Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis. The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Actual (reported)December 8, 2014
Actual (reported)December 22, 2014
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)October 9, 2018
Actual (reported)Measurement of Antifungal Activity of Loceryl Nail Lacquer
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Week 12
Absence of Dermatophytes in Nail Samples Culture
Week 12
Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails
Loceryl NL once/week for 12 weeks on right or left foot toenails
Loceryl NL + Cosmetic varnish once/week for 12 weeks
Loceryl NL once/week for 12 weeks
Principal Investigator
Reykjavik, Iceland
50 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2014
First Posted
December 22, 2014
Study Start
February 2014
Actual (reported)Loceryl once/week for additional 15 months
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Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
January 19, 2023
Results First Posted
October 9, 2018
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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