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

Primary Purpose

Foot Dermatoses

Status

Completed

Phase

Phase 4

Locations

Iceland

Study Type

Interventional

Intervention

Loceryl NL + Cosmetic varnish

Loceryl NL 12 weeks

Loceryl NL 15 months

About this trial

This is an interventional treatment trial for Foot Dermatoses focused on measuring Onychomycosis, antifungal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Principal Investigator

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Investigator blinded Loceryl NL+ Cosmetic varnish

Investigator blinded Loceryl NL alone

Arm Description

Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails

Loceryl NL once/week for 12 weeks on right or left foot toenails

Outcomes

Primary Outcome Measures

Measurement of Antifungal Activity of Loceryl Nail Lacquer

Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails

Secondary Outcome Measures

Absence of Dermatophytes in Nail Samples Culture

Full Information

NCT ID

NCT02321098

First Posted

December 8, 2014

Last Updated

January 17, 2023

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02321098

Brief Title

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

Acronym

COOL

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 (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Dermatoses

Keywords

Onychomycosis, antifungal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Masking Description

Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized. 15 months of treatment with Loceryl NL alone had an open study design

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigator blinded Loceryl NL+ Cosmetic varnish

Arm Type

Experimental

Arm Description

Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails

Arm Title

Investigator blinded Loceryl NL alone

Arm Type

Experimental

Arm Description

Loceryl NL once/week for 12 weeks on right or left foot toenails

Intervention Type

Drug

Intervention Name(s)

Loceryl NL + Cosmetic varnish

Intervention Description

Loceryl NL + Cosmetic varnish once/week for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Loceryl NL 12 weeks

Intervention Description

Loceryl NL once/week for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Loceryl NL 15 months

Intervention Description

Loceryl once/week for additional 15 months

Primary Outcome Measure Information:

Title

Measurement of Antifungal Activity of Loceryl Nail Lacquer

Description

Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Absence of Dermatophytes in Nail Samples Culture

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Principal Investigator

City

Reykjavik

Country

Iceland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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