Prospective, " Evaluator Blinded " Clinical Investigation to Evaluate the Effectiveness and Safety of Nailner Brush 2-in-1 in the Treatment of Onychomycosis

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Karo Pharma AB
Send
Updated on 30 September 2022
See if I qualify

Summary

Evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment compared to baseline.

Details
Condition Onychomycosis
Age 18years - 70years
Treatment topical treatment
Clinical Study IdentifierNCT05560841
SponsorKaro Pharma AB
Last Modified on30 September 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient having given freely her/his informed, written consent
Patient having a good general health
Age: between 18 and 70 years
Patient with superficial onychomycosis or light to moderate distolateral onychomycosis (without matrix involvement and involvement from 10 to 60%) on at least one great toenail
Patient with positive KOH staining
Patient cooperative and aware of the device modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected
Patient being psychologically able to understand information and to give their/his/her consent
Patient who agrees to refrain from receiving pedicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration
Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before screening visit and during all the study

Exclusion Criteria

Pregnant, breastfeeding woman or woman planning a pregnancy during the study
Patient enrolled in another clinical trial or which exclusion period is not over
Patient having used any systemic antifungal treatment in the last 6 months before screening and/or any topical antifungal treatment in the last months before screening visit
Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk
Patient suffering from a severe or progressive disease (at investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, poor blood circulation HIV, psoriasis, lichen planus, immunosuppressive pathology, moderate and high risk obesity (BMI ≥30)
Patient having a known allergy or hypersensitivity to one of the constituents of the investigational device
Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…)
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.