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Clinical Trials/NCT01180491
NCT01180491CompletedNot Applicable

A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

Moberg Pharma AB0 sites75 target enrollmentStarted: September 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Primary Endpoint
Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female patients aged 18 years or older
  • •25%-75% of the target nail altered as a result of onychomycosis
  • •Signed written informed consent

Exclusion Criteria

  • •Proximal subungual onychomycosis
  • •Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101
  • •Other conditions known to cause abnormal nail appearance
  • •Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.
  • •Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.
  • •Known allergy to any of the tested treatment products

Outcomes

Primary Outcomes

Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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