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

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ClinicalTrials.gov Identifier: NCT02321098
Recruitment Status : Completed
First Posted : December 22, 2014
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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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.


Condition or disease Intervention/treatment Phase
Foot Dermatoses Drug: Loceryl NL + Cosmetic varnish Drug: Loceryl NL 12 weeks Drug: Loceryl NL 15 months Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Primary Purpose: Treatment
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
Actual Study Start Date : February 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigator blinded Loceryl NL+ Cosmetic varnish
Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails
 Drug: Loceryl NL + Cosmetic varnish
Loceryl NL + Cosmetic varnish once/week for 12 weeks

Drug: Loceryl NL 15 months
Loceryl once/week for additional 15 months
Experimental: Investigator blinded Loceryl NL alone
Loceryl NL once/week for 12 weeks on right or left foot toenails
 Drug: Loceryl NL 12 weeks
Loceryl NL once/week for 12 weeks

Drug: Loceryl NL 15 months
Loceryl once/week for additional 15 months


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Absence of Dermatophytes in Nail Samples Culture [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321098


Locations
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Iceland
Principal Investigator
Reykjavik, Iceland
Sponsors and Collaborators
Galderma R&D
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02321098    
Other Study ID Numbers: RD.03.SPR29106
2013-000544-26 ( EudraCT Number )
First Posted: December 22, 2014    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galderma R&D:
Onychomycosis
antifungal
Additional relevant MeSH terms:
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Skin Diseases
Foot Dermatoses
Foot Diseases
 Amorolfine
Antifungal Agents
Anti-Infective Agents