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Completed

NCT Number: NCT02321098

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Principal Investigator

Reykjavik, Iceland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loceryl NL + Cosmetic varnish

Drug

Loceryl NL + Cosmetic varnish once/week for 12 weeks

Loceryl NL 12 weeks

Drug

Loceryl NL once/week for 12 weeks

Loceryl NL 15 months

Drug

Loceryl once/week for additional 15 months

Primary outcomes

  1. Measurement of Antifungal Activity of Loceryl Nail Lacquer

    Time frame: Week 12

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

Secondary outcomes

  1. Absence of Dermatophytes in Nail Samples Culture

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Acronym: COOL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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