OnychomycosisNCT06254027
Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment
A study testing Forte, Active Cover Light and Loceryl in people with Onychomycosis, run by Oystershell NV.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Forte, Active Cover Light and Loceryl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Sep 2025
- 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
- Healthy volunteers accepted
- 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: more than 18 years.
- Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablets).
- Patient with positive KOH staining.
- Patient cooperative and aware of the products 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 having stopped any systemic antifungal treatment since at least 6 months before screening.
- Patient having stopped any topical antifungal treatment since at least 3 months before screening.
- Patient who agrees to refrain from receiving pedicure/manicure, 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 12 weeks before screening visit, during all the study and at least 1 month after study end.
Who cannot join
- Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
- Patient considered by the investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial or which exclusion period is not over.
- 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 (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
- Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
- Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
About this study
Official title: Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis
The goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.
Read the detailed description
The primary objective of the study is to evaluate the effectiveness of FORTE (X92001873), ACTIVE COVER LIGHT (X92001872) and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.
The secondary objectives are to evaluate:
- Their effectiveness in the treatment of onychomycosis based on the microbiological cure (KOH staining and fungal culture)
- Their effectiveness in the improvement of nail appearance (onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening)
- Their effectiveness in the improvement of the quality of life of the patients using a specific questionnaire.
- Their effectiveness, tolerance and acceptability based on patient's opinion.
- Their safety The aim of the study is to demonstrate non-inferiority of the change in healthy nail surface from baseline to D270 of each product (μD) versus a predefined limit of 16% (clinically meaningful: μC) with a non-inferiority margin of δ = -5%
- Conditions
- Onychomycosis
- Being tested
- Forte, Active Cover Light, Loceryl
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForteDevice
Also called Excilor
One application per day for a complete treatment period.
Active Cover LightDevice
Also called Nailner
One application per day for a complete treatment period.
LocerylDrug
Also called Amorolfine
One application per week for a complete treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Forte | Experimental | Device:
One application per day for 9 months. Receives: Device: Forte |
| Active Cover Light | Experimental | Device:
One application per day for 9 months. Receives: Device: Active Cover Light |
| Loceryl 5% | Active comparator | Drug: Loceryl 5% One application per week for 3 months Receives: Drug: Loceryl |
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 270 days (9 months) of treatment with the test medical devices (FORTE or ACTIVE COVER LIGHT) or reference product (Loceryl) versus baseline value.
Measured: 270 days
Secondary outcomes (7)
Percentage of healthy surface (Performance)
Variation of the percentage of healthy nail surface versus baseline value.
Measured: 30 days; 90 days; 180 days
Microbiological efficacy: KOH staining (Performance)
Evaluation of microbiological efficacy versus baseline by KOH staining and fungal culture.
Measured: 270 days (month 9)
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Evaluation of the visual appearance of the nail by assessing following parameters: onycholysis, nail dystrophy, nail discoloration, and nail thickening by the investigator in live.
Each parameter is scored from 0 (none) - 4 (severe). The total score of all parameters is an indication of the visual appearance of the nail.
Measured: Baseline, 30 days; 90 days, 180 days; 270 days
Clinical efficacy: onychomycosis evolution (Performance)
Assessment of onychomycosis evolution by the investigator in live by scoring:
- - Failure: increase in the total infected area or aggravation
- - Status Quo
- - Improvement: decrease of the total infected area
- - Success: Disappearance of the total infected area
Measured: 30 days; 90 days; 180 days; 270 days
Impact on quality of life (Performance)
Evaluation of the impact on the quality of life (QoL) of patients using a validated questionnaire (NailQoL).
The questionnaire contains 15 questions, each using the scoring:
- 0 (never)
- 25 (rarely)
- 50 (sometimes)
- 75 (often)
- 100 (all the time)
Measured: Baseline, 30 days; 90 days, 180 days; 270 days
Subjective evaluation questionnaire for the patient (Performance)
Evaluation of efficacy, tolerance, and acceptability of the test medical devices and reference by the patients using a subjective evaluation questionnaire.
The subjective evaluation questionnaire uses a scoring (Completely Agree, Agree, Neutral, Disagree or Completely disagree) or uses 'Yes/No'- questions to be able to provide a score for performance.
Some open questions are added to allow the patients to elaborate on certain answers in order to have a better understanding of their response.
Measured: 14 days; 30 days; 90 days; 180 days; 270 days
Evaluation of tolerance
Evaluation of tolerance of the test medical devices and reference. Assessment is performed by the investigator via clinical evaluation and subject interrogation. The investigator will assign a score between 0 (bad tolerance) to 3 (very good tolerance).
Measured: 30 days; 90 days; 180 days; 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254027
- Sponsor's protocol ID
- 23E3473
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT06254027
- Acronym / sponsor ID
- 23E3473
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 12 Feb 2024 (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 goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.
Detailed description
The primary objective of the study is to evaluate the effectiveness of FORTE (X92001873), ACTIVE COVER LIGHT (X92001872) and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.
The secondary objectives are to evaluate:
- Their effectiveness in the treatment of onychomycosis based on the microbiological cure (KOH staining and fungal culture)
- Their effectiveness in the improvement of nail appearance (onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening)
- Their effectiveness in the improvement of the quality of life of the patients using a specific questionnaire.
- Their effectiveness, tolerance and acceptability based on patient's opinion.
- Their safety The aim of the study is to demonstrate non-inferiority of the change in healthy nail surface from baseline to D270 of each product (μD) versus a predefined limit of 16% (clinically meaningful: μC) with a non-inferiority margin of δ = -5%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Forte | Experimental | Device: ForteDevice: One application per day for 9 months. |
| Active Cover Light | Experimental | Device: Active Cover LightDevice: One application per day for 9 months. |
| Loceryl 5% | Active comparator | Drug: LocerylDrug: Loceryl 5% One application per week for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient having given freely her/his informed, written consent.
- Patient having a good general health.
- Age: more than 18 years.
- Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablets).
- Patient with positive KOH staining.
Key exclusion criteria (7 listed)
- Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
- Patient considered by the investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial or which exclusion period is not over.
- 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 (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
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 |
|---|---|---|
| ForteAlso: ExcilorOne application per day for a complete treatment period. | Device | Forte |
| Active Cover LightAlso: NailnerOne application per day for a complete treatment period. | Device | Active Cover Light |
| LocerylAlso: AmorolfineOne application per week for a complete treatment period. | Drug | Loceryl 5% |
Primary outcome
Percentage of healthy surface (Performance)
Time frame: 270 days
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical devices (FORTE or ACTIVE COVER LIGHT) or reference product (Loceryl) versus baseline value.
7 secondary outcomes
Percentage of healthy surface (Performance)
Time frame: 30 days; 90 days; 180 days
Microbiological efficacy: KOH staining (Performance)
Time frame: 270 days (month 9)
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Time frame: Baseline, 30 days; 90 days, 180 days; 270 days
Clinical efficacy: onychomycosis evolution (Performance)
Time frame: 30 days; 90 days; 180 days; 270 days
Impact on quality of life (Performance)
Time frame: Baseline, 30 days; 90 days, 180 days; 270 days
Subjective evaluation questionnaire for the patient (Performance)
Time frame: 14 days; 30 days; 90 days; 180 days; 270 days
Evaluation of tolerance
Time frame: 30 days; 90 days; 180 days; 270 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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 Forte, Active Cover Light and Loceryl in people with Onychomycosis, run by Oystershell NV.
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 11 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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?
Results are not available in the source record.
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: 270 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 12 Feb 2024.