OnychomycosisNCT01180491
A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
A study testing K101 nail solution in people with Onychomycosis, run by Moberg Pharma AB.
Trial summary
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- K101 nail solution
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
- Conditions
- Onychomycosis
- Being tested
- K101 nail solution
- Keywords
- Discoloured and deformed nails resulting from onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K101 nail solutionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180491
- Sponsor's protocol ID
- K101-50
- Status last verified
- Jun 2013
- First submitted
- 10 Aug 2010
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
- ClinicalTrials.gov ID
- NCT01180491
- Acronym / sponsor ID
- K101-50
- Conditions
- Onychomycosis
- Keywords
- Discoloured and deformed nails resulting from onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K101 nail solution | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing K101 nail solution in people with Onychomycosis, run by Moberg Pharma AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.