A randomized, open-label, active-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride (HCl) formulation versus 5% amorolfine nail lacquer for 48 weeks of treatment in patients with mild to moderate toenail onychomycosis

• Conditions: mild to moderate toenail onychomycosis; MedDRA version: 8.1Level: LLTClassification code 10030338Term: Onychomycosis

• Registration Number: EUCTR2006-003570-10-FI
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 926

Inclusion Criteria

1. Outpatients of either sex and 12 – 75 years of age.

2. Clinically suspected dermatophyte infection confirmed by a positive KOH microscopy and culture performed by the central mycology laboratory.

3. The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.

4. At least 1 large (great) toenail meeting the infection criteria. If more than 1 large toenail is infected and meets inclusion/exclusion criteria, both toenails should be sampled for culture. The toenail with greater involvement will be selected as the target nail. If both large toenails have the same degree of involvement, the right toenail will be selected as the target” toenail.

5. The target large toenail must be confirmed as having at least a minimum of 1 mm growth, measured by the site, within the 4-6 week screening period.
Are the trial subjects under 18? yes
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. Patients who have had systemic antifungal therapy within 6 months prior to screening for the study.

2. Patients who have used prescription or commercially available topical antifungal therapy indicated for onychomycosis within 3 months prior to screening, or commercially available topical antifungal therapy for onychomycosis or any other commercially available topical antifungal therapy applied directly to the toenails within 1 month prior to screening.

3. Patients who have used other investigational drugs at the time of enrollment or within 30 days.

4. Nail infection due to an organism other than a dermatophyte (mixed infections[dermatophyte and non-dermatophyte] are not allowed).

5. The target foot has severe plantar (moccasin) tinea pedis infection that would require systemic therapy (as determined by the investigator). Mild to moderate tinea pedis infection should be treated with Lamisil® DermGel, or with Lamisil® Cream if
Lamisil® DermGel is unavailable, to eliminate fungal reservoir as needed prior to baseline or at any time during the trial. Other topical treatments indicated for tinea pedis may be recommended at the discretion of the investigator.

6. Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.

7. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.

8. Patients with abnormalities of the target nail that could prevent obtaining a normal appearing nail if clearing of the infection is achieved (i.e. tumors, chemical damage, genetic disorders, pigmentary disorders, psoriasis, collagen vascular disease, lichen planus, peripheral vascular disease, traumatic onychodystrophy due to chronic stimuli, structural deformity, severe diabetic foot neuropathy).

9. Patients with abnormal findings (laboratory or physical) or conditions which are considered to be clinically important by the investigator and indicative of conditions that could jeopardize patient safety or interfere with the interpretation of the results of the study. Please note: diabetic patients may be enrolled in the study if their diabetes is well-controlled.

10. Patients with a history of malignancy of any organ system within the past year, whether or not there is recurrence or metastases, with the exception of localized basal cell or squamous cell carcinoma of the skin for which medical intervention should be planned.

11. Known pregnant or lactating women at the time of enrollment or patients who plan to become pregnant during the study period.

12. Patients with sensitivity to terbinafine or amorolfine or excipients of the formulations.

13. Patients not likely or unable to cooperate with study requirements including those witha recent history of alcohol or drug abuse, or are currently known to abuse alcohol or drugs.

14. Patients not willing to stop professional pedicures, or not willing to remove or discontinue the use of any nail polish product or other nail cosmetic product on their toenails at the screening visit and throughout the study.

Study & Design

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