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

Foot Dermatoses Clinical Trial

— COOL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321098
• Other study ID #: RD.03.SPR.29106
• Secondary ID: 2013-000544-26
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot Dermatoses
• Skin Diseases

Intervention

Drug:
• Loceryl NL + Cosmetic varnish
Loceryl NL + Cosmetic varnish once/week for 12 weeks
• Loceryl NL 12 weeks
Loceryl NL once/week for 12 weeks
• Loceryl NL 15 months
Loceryl once/week for additional 15 months

Locations

Country	Name	City	State
Iceland	Principal Investigator	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absence of Dermatophytes in Nail Samples Culture		Week 12