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

NCT02321098 | Completed Phase 4 Results

• 2 other identifiers: RD.03.SPR.291062013-000544-26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Dermatoses

Keywords

Onychomycosis; antifungal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Absence of Dermatophytes in Nail Samples Culture

  Week 12

Study Arms (2)

Investigator blinded Loceryl NL+ Cosmetic varnish

EXPERIMENTAL

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

Drug: Loceryl NL + Cosmetic varnish; Drug: Loceryl NL 15 months

Investigator blinded Loceryl NL alone

EXPERIMENTAL

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

Drug: Loceryl NL 12 weeks; Drug: Loceryl NL 15 months

Interventions

Loceryl NL + Cosmetic varnish DRUG

Loceryl NL + Cosmetic varnish once/week for 12 weeks

Investigator blinded Loceryl NL+ Cosmetic varnish

Loceryl NL 12 weeks DRUG

Loceryl NL once/week for 12 weeks

Investigator blinded Loceryl NL alone

Loceryl NL 15 months DRUG

Loceryl once/week for additional 15 months

Investigator blinded Loceryl NL alone; Investigator blinded Loceryl NL+ Cosmetic varnish

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Principal Investigator

Reykjavik, Iceland

Location

MeSH Terms

Conditions

Foot Dermatoses; Onychomycosis

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases

Results Point of Contact

• Title: Farzaneh Sidou Clinical Project Manager
• Organization: Galderma

farzaneh.sidou@galderma.com

04 93 95 70 51

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 22, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 19, 2023
• Results First Posted: October 9, 2018

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)