A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 26, 2013
June 1, 2013
2 months
August 10, 2010
June 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients aged 18 years or older
- %-75% of the target nail altered as a result of onychomycosis
- Signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moberg Pharma ABlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 12, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 26, 2013
Record last verified: 2013-06