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

Phase 4

Completed

• Conditions: Foot Dermatoses
• Interventions: Drug: Loceryl NL 12 weeks; Drug: Loceryl NL + Cosmetic varnish; Drug: Loceryl NL 15 months

• Registration Number: NCT02321098
• Lead Sponsor: Galderma R&D

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).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2018-03-02
• Results First Submitted QC: 2018-03-02
• Results First Posted: 2018-10-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigator blinded Loceryl NL+ Cosmetic varnish	Loceryl NL 15 months	Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails
Investigator blinded Loceryl NL alone	Loceryl NL 15 months	Loceryl NL once/week for 12 weeks on right or left foot toenails
Investigator blinded Loceryl NL alone	Loceryl NL 12 weeks	Loceryl NL once/week for 12 weeks on right or left foot toenails
Investigator blinded Loceryl NL+ Cosmetic varnish	Loceryl NL + Cosmetic varnish	Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails

Primary Outcome Measures

Name	Time	Method
Measurement of Antifungal Activity of Loceryl Nail Lacquer	Week 12	Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails

Secondary Outcome Measures

Name	Time	Method
Absence of Dermatophytes in Nail Samples Culture	Week 12

Trial Locations

Locations (1)

Principal Investigator; 🇮🇸 Reykjavik, Iceland