CompletedPhase 4

Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish

Iceland50 participantsStarted 2014-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail * Subjects must have maximum of 50% of nail distal edge involved * Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening Exclusion Criteria: * Subjects with clinically important abnormal physical findings at the Screening/Baseline visit * Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit * Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs

What they're measuring

Measurement of Antifungal Activity of Loceryl Nail Lacquer

Timeframe: Week 12

Trial details

NCT IDNCT02321098

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2018-03-02

View on ClinicalTrials.gov More Foot Dermatoses trials