OnychomycosisNCT05560841
Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis
A study testing topical treatment in people with Onychomycosis, run by Karo Pharma AB at 2 sites in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- topical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTunisia
- Study dates
- 28 Jul 2022to 10 Apr 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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…).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prospective, " Evaluator Blinded " Clinical Investigation to Evaluate the Effectiveness and Safety of Nailner Brush 2-in-1 in the Treatment of Onychomycosis
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.
- Conditions
- Onychomycosis
- Being tested
- topical treatment
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical treatmentDevice
Topical application of Nailner brush 2in1 for toenail onychomycosis
| Study group | Role | What they receive |
|---|---|---|
| Nailner 2 in 1 | Experimental | Nailner Brush 2-in-1 (5ml)
Liquid solution in glass bottle with a brush applicator Topical application twice a day during 4 weeks then once a day until 6 months Receives: Device: topical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To 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
Mean variation from baseline of the percentage of healthy surface after 6 months of treatment. Evaluation is done in blind by digital analysis of photographs of the infected toenail.
Measured: Day 180
Secondary outcomes (6)
To 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 1 and 3 months of treatment compared to baseline
Mean variation from baseline of the percentage of healthy surface after 1 and 3 months of treatment. Evaluation is done in blind by digital analysis of photographs of the infected toenail.
Measured: Day 30, Day 90
To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)
Percentage of patients with positive KOH staining at baseline and 3 and 6 months after treatment.
Measured: Day 90, Day 180
To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance
Mean variation from baseline of the onychomycosis evaluation ( onycholysis, nail dystrophy, nail discoloration and nail thickening) as assessed by the investigator in live at baseline and 1, 3 and 6 months after treatment.
Measured: Day 30, Day 90, Day180
To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.
Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL p
Measured: Day 7, Day 30, Day 90, Day 180
To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 1, 3 and 6 months after treatment
Measured: Day 30, Day 90, Day 180
To evaluate the safety of of Nailner Brush 2-in-1
Product safety will be assessed by collection of Adverse Events (Aes) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start28 Jul 2022
- Primary completion12 Jan 2023
- Study completion10 Apr 2023
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karo Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pr. Nejib DOSS, MD, Principal investigator, Dermascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560841
- Sponsor's protocol ID
- 21E4142
- Status last verified
- Oct 2023
- First submitted
- 15 Sep 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, " Evaluator Blinded " Clinical Investigation to Evaluate the Effectiveness and Safety of Nailner Brush 2-in-1 in the Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT05560841
- Acronym / sponsor ID
- 21E4142
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karo Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 29 Sep 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
| Arm | Type | Receives |
|---|---|---|
| Nailner 2 in 1 | Experimental | Device: topical treatmentNailner Brush 2-in-1 (5ml) Liquid solution in glass bottle with a brush applicator Topical application twice a day during 4 weeks then once a day until 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
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 |
|---|---|---|
| topical treatmentTopical application of Nailner brush 2in1 for toenail onychomycosis | Device | Nailner 2 in 1 |
Primary outcome
To 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
Time frame: Day 180
Mean variation from baseline of the percentage of healthy surface after 6 months of treatment. Evaluation is done in blind by digital analysis of photographs of the infected toenail.
6 secondary outcomes
To 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 1 and 3 months of treatment compared to baseline
Time frame: Day 30, Day 90
To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)
Time frame: Day 90, Day 180
To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance
Time frame: Day 30, Day 90, Day180
To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.
Time frame: Day 7, Day 30, Day 90, Day 180
To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.
Time frame: Day 30, Day 90, Day 180
To evaluate the safety of of Nailner Brush 2-in-1
Time frame: Day 180
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 4 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Pr. Nejib DOSS, MD principal investigator
Dermascan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical treatment in people with Onychomycosis, run by Karo Pharma AB at 2 sites in Tunisia.
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 9 inclusion and 7 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To 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 (time frame: Day 180). 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 4 Oct 2023.