A double-blind, randomized, multi-centre, placebo-controlled study of efficacy and safety of topical K101 in twelve months treatment of distal subungual onychomycosis (DSO)

• Conditions: Distal subungual onychomycosis (DSO); MedDRA version: 9.1Level: LLTClassification code 10030338Term: Onychomycosis

• Registration Number: EUCTR2009-013261-26-SE
• Lead Sponsor: Moberg Derma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female (including fertile women)
2. 18 years or older
3. Distal subungual onychomycosis of at least one of the great toe(s) affecting 20% to 60% of the target nail (verified by blinded assessor before randomization)
4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
5. Signed written informed consent

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. Proximal subungual onychomycosis
2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
3. ”Spike” of onychomycosis extending to eponychium of the target nail
4. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
5. Other conditions than DSO known to cause abnormal nail appearance
6. Topical treatment of the nails with other antifungal medication within 1 month before screening
7. Systemic use of antifungal treatment within 3 months before screening
8. Signs of severe peripheral circulatory insufficiency
9. Immunosuppression
10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
11. Known allergy to any of the tested treatment products
12. Subject who has been previously randomized to treatment in the phase III study K70-2 investigating K101

Study & Design

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