Phase 4
Completed N=20
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Foot Dermatoses
Source: ClinicalTrials.gov NCT02679911 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Percent of "in Label" Adherent Subjects — 85; 60 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of "in Label" Adherent Subjects |
85; 60 | — |
| SECONDARY Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 |
60; 60 | — |
Eligibility Criteria
Inclusion Criteria
- Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit,
- Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
- Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline,
- Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
Exclusion Criteria
- Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy),
- Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure),
- Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.
Data sourced from ClinicalTrials.gov (NCT02679911). 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.