A study to determine the safety and efficacy of a terbinafine topical formulation system in subjects with onychomycosis in laser treated toenails versus ciclopirox lacquer in intact toenails

• Conditions: Distal/lateral Subungual onychomycosis (DSO) caused by dermatophytes; MedDRA version: 8.1Level: LLTClassification code 10030338Term: Onychomycosis

• Registration Number: EUCTR2006-005895-42-IS
• Lead Sponsor: TLT Medical Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-05
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

1)Male or female between 18 and 75 years of age of any race.
2)Subjects must present with distal/lateral subungual onychomycosis of at least one great toenail at Visit 1 with a degree of involvement of 15% to 75% at screening day.
3)A positive KOH examination and a positive dermatophyte culture using a validated test from nail specimens taken from the target nails within 20 to 35 days prior to the Day 1 visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Subjects with nail infections due to organisms other than dermatophytes (e.g. Candida or non-dermatophyte molds) as determined using a suitable culture and proper sampling method; i.e. no mixed infections.
2)Pregnant or lactating women.
3)Subjects with known hypersensitivity to terbinafine or ciclopirox or to any of the ingredients in the study drugs.
4)Subjects with structural deformities of the affected nails, toes or foot that would interfere with the digital photography needed for the planimetric analyses and/or appropriate immobilization of the target toe during the laser treatment.
5)Subjects that had used oral antifungals (e.g. Lamisil or Sporanox) to treat onychomycosis during the previous 6 months.
6)Subjects that had used topical antifungal formulation (e.g. Mycoster, Batrafen or Loceryl) to treat onychomycosis during the last 3 months.
7)Patients with a dermatophytoma.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified