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

Galderma

Status and phase: Completed; Phase 4

Conditions: Foot Dermatoses

Treatments: Drug: Loceryl NL 12 weeks; Drug: Loceryl NL + Cosmetic varnish; Drug: Loceryl NL 15 months

Study type: Interventional

Funder types: Industry

Identifiers

NCT02321098

2013-000544-26 (EudraCT Number)

RD.03.SPR.29106

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Investigator blinded Loceryl NL+ Cosmetic varnish

Experimental group

Description:

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

Treatment:

Drug: Loceryl NL 15 months

Drug: Loceryl NL + Cosmetic varnish

Investigator blinded Loceryl NL alone

Experimental group

Description:

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

Treatment:

Drug: Loceryl NL 15 months

Drug: Loceryl NL 12 weeks