A multi-centre, randomized, parallel groups, vehicle and active controlled study of amorolfine 4% and 10% nail lacquer new formulation in the topical treatment of distal and lateral subungual toenail onychomycosis

• Conditions: Distal and lateral subungual onychomycosis; MedDRA version: 8.1Level: LLTClassification code 10030338

• Registration Number: EUCTR2006-000974-54-IS
• Lead Sponsor: GALDERMA Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-25
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Male or female adult aged 18 to 65.

2. Subject with clinically suspected distal and lateral subungual onychomycosis due to dermatophytes and involving at least one great toe nail to be selected as the Target Toenail” for planimetry.

3. At least one great toenail with at least 25% of the nail surface area with disease involvement but no involvement of the proximal 1/3 of the nail.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject with clinically important abnormality which could interfere with the objectives of the study or the interpretation of the findings.

2. Subject with the presence of spikes or subungual dermatophytoma.

3. Subject with total dystrophic, white superficial or proximal onychomycosis

Study & Design

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