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CompletedNCT01180491Updated Jun 26, 2013

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

An interventional study of K101 nail solution in Onychomycosis, sponsored by Moberg Pharma AB. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by Moberg Pharma AB · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
75
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Onychomycosis

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Keywords

  • Discoloured and deformed nails resulting from onychomycosis
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In context

Onychomycosis

147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.

This study's enrollment of 75 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.

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Lead sponsor

Moberg Pharma AB is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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
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Study design

Phase
Not applicable
Enrollment
75 participants (actual)

Interventions

  • DeviceK101 nail solution
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What researchers measure

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.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01180491
Lead sponsor
Moberg Pharma AB
Responsible party
Sponsor
First posted
Aug 12, 2010
Start date
Sep 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Jun 26, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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