Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish (COOL)

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

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.

Study Overview

• Status: Completed
• Conditions: Foot Dermatoses
• Intervention / Treatment: Drug: Loceryl NL + Cosmetic varnish; Drug: Loceryl NL 15 months; Drug: Loceryl NL 12 weeks

Detailed Description

Study center:

A total of 50 subjects were to be included in 1 site in Iceland.

Methodology:

• 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.

• All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iceland
  • Reykjavik, Iceland
    • Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigator blinded Loceryl NL+ Cosmetic varnish; Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails	Drug: Loceryl NL + Cosmetic varnish; Loceryl NL + Cosmetic varnish once/week for 12 weeks; Drug: Loceryl NL 15 months; Loceryl once/week for additional 15 months
Experimental: Investigator blinded Loceryl NL alone; Loceryl NL once/week for 12 weeks on right or left foot toenails	Drug: Loceryl NL 15 months; Loceryl once/week for additional 15 months; Drug: Loceryl NL 12 weeks; Loceryl NL once/week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Antifungal Activity of Loceryl Nail Lacquer	Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Absence of Dermatophytes in Nail Samples Culture	Week 12

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Onychomycosis; antifungal
• Additional Relevant MeSH Terms: Foot Diseases; Skin Diseases; Foot Dermatoses; Anti-Infective Agents; Antifungal Agents; Amorolfine
• Other Study ID Numbers: RD.03.SPR.29106; 2013-000544-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No