An interventional study of Forte and Active Cover Light in Onychomycosis, sponsored by Oystershell NV. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
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.
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:
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's planned enrollment of 132 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.
Exclusion Criteria:
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.
Device: One application per day for 9 months.
Device: Forte
Device: One application per day for 9 months.
Device: Active Cover Light
Drug: Loceryl 5% One application per week for 3 months
Drug: Loceryl
One application per day for a complete treatment period.
Also known as: Excilor
One application per day for a complete treatment period.
Also known as: Nailner
One application per week for a complete treatment period.
Also known as: Amorolfine
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.
Time frame: 270 days
Percentage of healthy surface (Performance)
Variation of the percentage of healthy nail surface versus baseline value.
Time frame: 30 days; 90 days; 180 days
Microbiological efficacy: KOH staining (Performance)
Evaluation of microbiological efficacy versus baseline by KOH staining and fungal culture.
Time frame: 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.
Time frame: 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: 1. - Failure: increase in the total infected area or aggravation 2. - Status Quo 3. - Improvement: decrease of the total infected area 4. - Success: Disappearance of the total infected area
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 30 days; 90 days; 180 days; 270 days
No study locations are listed for this record.
Start is estimated for Mar 2024; primary completion for Jun 2025, 15 months later.
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 planned 15 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oystershell NV