Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Foot Dermatoses
Intervention: Loceryl Nail Lacquer (Drug); Loceryl Nail Lacquer (Drug); Loceryl Nail Lacquer follow up period (Drug); Cosmetic varnish (Other)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Galderma
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.
Clinical Details
Official title: Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Secondary outcome: Presence/absence of Dermatophytes in nail samples culture
Detailed description:
Study center:
A two period study: A total of 50 subjects were to be included in 1 site in Iceland.
Methodology:
1. Treatment period:
- Group Loceryl Nail Lacquer+ Cosmetic Varnish:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected
toenails,
- Cosmetic varnish to be applied once weekly for 12 weeks on all affected
toenails and/or all toenails.
- Group Loceryl Nail Lacquer alone:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected
toenails.
At week 12 if no clinical sign of clinical aggravation of Onychomycosis, subjects could
enter into a Follow-up period.
2. Follow-up period:
Subjects were to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or
less in case of complete cure).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Principal Investigator, Reykjavik, Iceland
Additional Information
Starting date: February 2014
Last updated: December 19, 2014
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