An interventional study of Enriched and Loceryl 5% in Onychomycosis, sponsored by Oystershell NV. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
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).
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's planned enrollment of 88 is above the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Oystershell NV is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 should use a regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.
Exclusion Criteria:
- 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, , psoriasis, lichen planus, pathology… 6. Patient having a known allergy or to one of the constituents of the tested products.
7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To be used twice daily during 9 month
Device: Enriched
To be used 1 per week during 9 months
Drug: Loceryl 5%
To be used twice a day
To be used once a week
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.
Time frame: 270 days
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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 90 days, 180 days, 270 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Jul 2025, 8 months.
Of 21 interventional studies with no phase under Onychomycosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 18. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Amorolfine
Oystershell NV