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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Amorolfine; Antifungal Agents; Miconazole

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