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

RD.03.SPR.29106

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.

2014-02-01

2016-01-01

2016-01-01

Completed

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized.\n\n15 months of treatment with Loceryl NL alone had an open study design', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2023-01-19