Onychomycosis of ToenailNCT04961684
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
A study testing Solver Pen and Loceryl 5% in people with Onychomycosis of Toenail, run by Oystershell NV at 1 site in Tunisia.
Trial summary
The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Solver Pen and Loceryl 5%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Feb 2020to 22 Sep 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient having given her/his informed, written consent.
- Patient cooperative and aware of the 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.
- Age: more than 18 years.
- Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
- Patient with positive KOH staining.
- Patient having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
- Women of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the investigation;
- Patient considered by the Investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial during the test period.
- Subject having a known allergy to one of the constituents of the tested products.
- Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
- Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
- Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Solver Pen, Loceryl 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solver PenDevice
One application per day for 3 months
Loceryl 5%Drug
One application per week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Solver Pen | Experimental | Not described Receives: Device: Solver Pen |
| Loceryl 5% | Active comparator | Not described Receives: Drug: Loceryl 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healthy surface (performance)
Variation of the percentage of healthy surface after 90 days of treatment with the test medical device or reference versus baseline value. Evaluation is done in blind by digital analysis of photographs of the great, infected toenail.
Measured: 90 days
Secondary outcomes (12)
Percentage of healthy surface (performance)
Variation of the percentage of healthy surface after 30 and 60 days of treatment with the test medical device or reference versus baseline. Blinded evaluation is performed by digital analysis of photographs of the great, infected toenail.
Measured: 30 and 60 days
Microbiological efficacy: KOH staining (performance)
Evaluation of microbiological efficacy of both treatments by KOH staining on D90 versus baseline.
Measured: 90 days
Microbiological efficacy: fungal culture (performance)
Evaluation of microbiological efficacy of both treatments by fungal culture on D90 versus baseline.
Measured: 90 days
Clinical efficacy: onychomycosis evolution (performance)
Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of onychomycosis evolution on a 4-point scale (failure to success)
Measured: 30, 60 and 90 days
Clinical efficacy: onycholysis (performance)
Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of onycholysis on a 5-point scale (none to severe)
Measured: 30, 60 and 90 days
Clinical efficacy: nail distrophy (performance)
Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail distrophy on a 5-point scale (none to severe)
Measured: 30, 60 and 90 days
Clinical efficacy: nail discoloration (performance)
Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail discoloration on a 5-point scale (none to severe)
Measured: 30, 60 and 90 days
Clinical efficacy: nail thickening (performance)
Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail thickening on a 5-point scale (none to severe)
Measured: 30, 60 and 90 days
Impact on quality of life (performance)
Evaluation of the impact on the quality of life (QoL) of the patients using a validated questionnaire (NailQoL: Nail Questionnaire Of Life from 0=no impact on life quality to 100=maximum impact on life quality) before (baseline) and 60 and 90 days of treatment with the test medical device or reference, respectively.
Measured: 60 and 90 days
Subjective evaluation questionnaire for the patient (performance)
Evaluation of efficacy, tolerance, and acceptability cosmetic aspect, usability…) of the investigational device by the patients using a subjective evaluation questionnaire (answers to questions with 5 modalities from "strongly disagree" to "strongly agree"), performed at each visit and at D14 (via phone).
Measured: 14, 30, 60 and 90 days of treatment
Assessment of local tolerance by the investigator (safety and tolerability)
Evaluation of local tolerance of the test medical device at each visit. Assessment is performed by the investigator via clinical evaluation and subject interrogation on a scale from 0 (bad tolerance) to 3 (very good tolerance)
Measured: 30, 60 and 90 days
Incidence of Adverse events (safety and tolerability)
Collection of Adverse events and adverse device effects throughout the study
Measured: 30, 60 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start10 Feb 2020
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nejib Doss, MD, Principal investigator, Eurofins Dermscan Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961684
- Sponsor's protocol ID
- 19E2407
- Status last verified
- Jul 2021
- First submitted
- 31 May 2021
- Last updated
- 14 Jul 2021
- 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT04961684
- Acronym / sponsor ID
- 19E2407
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 14 Jul 2021 (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.
The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solver Pen | Experimental | Device: Solver Pen |
| Loceryl 5% | Active comparator | Drug: Loceryl 5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient having given her/his informed, written consent.
- Patient cooperative and aware of the 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.
- Age: more than 18 years.
- Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
Key exclusion criteria (7 listed)
- Pregnant or nursing woman or planning a pregnancy during the investigation;
- Patient considered by the Investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial during the test period.
- Subject having a known allergy to one of the constituents of the tested products.
- Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
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 |
|---|---|---|
| Solver PenOne application per day for 3 months | Device | Solver Pen |
| Loceryl 5%One application per week for 3 months | Drug | Loceryl 5% |
Primary outcome
Percentage of healthy surface (performance)
Time frame: 90 days
Variation of the percentage of healthy surface after 90 days of treatment with the test medical device or reference versus baseline value. Evaluation is done in blind by digital analysis of photographs of the great, infected toenail.
12 secondary outcomes
Percentage of healthy surface (performance)
Time frame: 30 and 60 days
Microbiological efficacy: KOH staining (performance)
Time frame: 90 days
Microbiological efficacy: fungal culture (performance)
Time frame: 90 days
Clinical efficacy: onychomycosis evolution (performance)
Time frame: 30, 60 and 90 days
Clinical efficacy: onycholysis (performance)
Time frame: 30, 60 and 90 days
Clinical efficacy: nail distrophy (performance)
Time frame: 30, 60 and 90 days
Clinical efficacy: nail discoloration (performance)
Time frame: 30, 60 and 90 days
Clinical efficacy: nail thickening (performance)
Time frame: 30, 60 and 90 days
Impact on quality of life (performance)
Time frame: 60 and 90 days
Subjective evaluation questionnaire for the patient (performance)
Time frame: 14, 30, 60 and 90 days of treatment
Assessment of local tolerance by the investigator (safety and tolerability)
Time frame: 30, 60 and 90 days
Incidence of Adverse events (safety and tolerability)
Time frame: 30, 60 and 90 days
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 14 Jul 2021.
- 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.
Nejib Doss, MD principal investigator
Eurofins Dermscan Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solver Pen and Loceryl 5% in people with Onychomycosis of Toenail, run by Oystershell NV at 1 site 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 8 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 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of healthy surface (performance) (time frame: 90 days). 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 14 Jul 2021.