Phase 4
N=50
Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
Foot Dermatoses
Bottom Line
View on ClinicalTrials.gov: NCT02321098 ↗Enrolled (actual)
50
Serious AEs
2.5%
Results posted
Oct 2018
Primary outcome: Primary: Measurement of Antifungal Activity of Loceryl Nail Lacquer — 53.6; 53.5 Milimeter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Loceryl NL + Cosmetic varnish (Drug); Loceryl NL 12 weeks (Drug); Loceryl NL 15 months (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2016
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 | — |
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.
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). 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.