Phase 4
Completed N=50
Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
Foot Dermatoses
Source: ClinicalTrials.gov NCT02321098 ↗
Enrolled (actual)
50
Serious AEs
2.5%
Results posted
Oct 2018
Primary outcomePrimary: Measurement of Antifungal Activity of Loceryl Nail Lacquer — 53.6; 53.5 Milimeter
◆ Published Evidence
Emerging
9citations · ~1 / year
Application of cosmetic nail varnish does not affect the antifungal efficacy of amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis: results of a randomised active-controlled study and in vitro assays.
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.
Linked Publications
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Application of cosmetic nail varnish does not affect the antifungal efficacy of amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis: results of a randomised active-controlled study and in vitro assays.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Antifungal Activity of Loceryl Nail Lacquer |
53.6; 53.5 | — |
| SECONDARY Absence of Dermatophytes in Nail Samples Culture |
25; 23 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02321098) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.