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

Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Foot Dermatoses

Intervention: Loceryl Nail Lacquer (Drug); Loceryl Nail Lacquer (Drug); Loceryl Nail Lacquer follow up period (Drug); Cosmetic varnish (Other)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Galderma

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.

Clinical Details

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 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

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

Secondary outcome: Presence/absence of Dermatophytes in nail samples culture

Detailed description: Study center: A two period study: A total of 50 subjects were to be included in 1 site in Iceland. Methodology: 1. Treatment period:

- 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. At week 12 if no clinical sign of clinical aggravation of Onychomycosis, subjects could enter into a Follow-up period. 2. Follow-up period: Subjects were to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Principal Investigator, Reykjavik, Iceland
Additional Information

Starting date: February 2014
Last updated: December 19, 2014

Page last updated: August 23, 2015

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