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Clinical Trials/EUCTR2009-013261-26-SE
EUCTR2009-013261-26-SEActive, not recruitingNot Applicable

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)

Moberg Derma AB0 sitesStarted: July 6, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
Moberg Derma AB

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