OnychomycosisNCT06689852
CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
A study testing Enriched and Loceryl 5% in people with Onychomycosis, run by Oystershell NV at 1 site in France.
Trial summary
The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Enriched and Loceryl 5%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 1. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. 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).
- 5. Patient with positive KOH staining. 6. 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.
- 7. Patient being psychologically able to understand information and to give their/his/her consent.
- 8. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.
- 9. Patient who agree 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.
- 10. 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
- 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. Patient considered by the investigator likely to be non-compliant with the protocol. 3. Patient enrolled in another clinical trial or which exclusion period is not over. 4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. 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… 6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
- 7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurofins Dermscan Pharmascan
Villeurbanne, France, 69100
About this study
Official title: MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
Read the detailed description
Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).
- Conditions
- Onychomycosis
- Being tested
- Enriched, Loceryl 5%
- Keywords
- onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnrichedDevice
To be used twice a day
Loceryl 5%Drug
To be used once a week
| Study group | Role | What they receive |
|---|---|---|
| Enriched | Experimental | To be used twice daily during 9 month Receives: Device: Enriched |
| Loceryl | Experimental | To be used 1 per week during 9 months Receives: Drug: Loceryl 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded evaluation of the percentage of healthy nail surface
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
Measured: 270 days
Secondary outcomes (7)
Percentage of healthy surface (performance)
Variation of the percentage of healthy surface after 90 days (3 months) and 180 days (6 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
Measured: 90 days, 180 days
Mirobiological efficacy ; KOH staining (Performance)
Evaluation of microbiological efficacy of both treatments versus baseline by KOH staining and fungal culture at D270 (month 9)
Measured: 270 days
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Assessment of clinical efficacy of both treatments on D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9) by evaluation of the 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: 90 days, 180 days, 270 days
Clinical efficacy: onychomycosis evolution (Performance)
Assessment of onychomycosis evolution on D90 (month 3), D180 (month 6) and D270 (month 9) by the investigator in live
- 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: 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) on D0 (baseline) and 180 (month 6) and 270 (month 9) days of treatment with the test medical device or reference, respectively
Measured: 180 days, 270 days
Subjective evaluation questionnaire for the patient (Performance)
Evaluation of efficacy, tolerance, and acceptability of the test medical device and reference by thepatients using a subjective evaluation questionnaire, performed at D14, D90 (month 3), D180 (month 6) and D270 (month 9).
Measured: 14 days, 90 days, 180 days, 270 days
Evaluation of tolerance
Evaluation of tolerance of the test medical device and reference product at D90 (month 3), D180 (month 6) and D270 (month 9). 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: 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 posted15 Nov 2024
- Study start30 Oct 2024
- Primary completion4 Jul 2025
- Study completionApr 2026 (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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689852
- Sponsor's protocol ID
- 23E1728
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. 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 PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
- ClinicalTrials.gov ID
- NCT06689852
- Acronym / sponsor ID
- 23E1728
- Conditions
- Onychomycosis
- Keywords
- onychomycosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Nov 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 efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
Detailed description
Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched | Experimental | Device: EnrichedTo be used twice daily during 9 month |
| Loceryl | Experimental | Drug: Loceryl 5%To be used 1 per week during 9 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. 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).
- 5. Patient with positive KOH staining. 6. 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.
- 7. Patient being psychologically able to understand information and to give their/his/her consent.
- 8. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.
- 9. Patient who agree 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.
Key exclusion criteria (2 listed)
- 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. Patient considered by the investigator likely to be non-compliant with the protocol. 3. Patient enrolled in another clinical trial or which exclusion period is not over. 4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. 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… 6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
- 7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
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 |
|---|---|---|
| EnrichedTo be used twice a day | Device | Enriched |
| Loceryl 5%To be used once a week | Drug | Loceryl |
Primary outcome
Blinded evaluation of the percentage of healthy nail surface
Time frame: 270 days
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
7 secondary outcomes
Percentage of healthy surface (performance)
Time frame: 90 days, 180 days
Mirobiological efficacy ; KOH staining (Performance)
Time frame: 270 days
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Time frame: 90 days, 180 days, 270 days
Clinical efficacy: onychomycosis evolution (Performance)
Time frame: 90 days, 180 days, 270 days
Impact on quality of life (Performance)
Time frame: 180 days, 270 days
Subjective evaluation questionnaire for the patient (Performance)
Time frame: 14 days, 90 days, 180 days, 270 days
Evaluation of tolerance
Time frame: 90 days, 180 days, 270 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched and Loceryl 5% in people with Onychomycosis, run by Oystershell NV at 1 site in France.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Laune, Project manager (+33472823656, manon.laune@cpt.eurofinseu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinded evaluation of the percentage of healthy nail surface (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 3 Sep 2025.