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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01180491
Other study ID # K101-50
Secondary ID
Status Completed
Phase N/A
First received August 10, 2010
Last updated June 25, 2013
Start date September 2010
Est. completion date November 2010

Study information

Verified date June 2013
Source Moberg Derma AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Device:
K101 nail solution


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Moberg Derma AB

Outcome

Type Measure Description Time frame Safety issue
Primary 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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