An interventional study of Excilor Forte and Loceryl 5% in Onychomycosis of Toenail, sponsored by Oystershell NV. Completed at 2 sites in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
This study evaluates the effect of the medical device "Excilor® Forte" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 102 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.
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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.
Subject having given her/his informed, written consent.
Exclusion Criteria:
Patient enrolled in another clinical trial during the test period.
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.
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.
One application of the MD daily (at same time point), preferably after showering/bathing, during the complete study period.
Device: Excilor Forte
One application per week of the positive control Loceryl 5% during the whole study period.
Drug: Loceryl 5%
1 application per day during 6 months
1 application per week during 6 months
Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups
Time frame: After 30, 60, 120 and 180 days of treatment
Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.
Onycholysis, nail distrophy, nail discoloration, and nail thickening was evaluated by a blinded investigator, using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe. Onychomycosis evolution was scored as follows: 1 = failure (aggravation, increase total infected area), 2 = status quo, 3 = improvement (decrease of total infected area), 4 = success: disappearance of the total infected area. In order to compare changes in nail dystrophy, discoloration, and nail thickening between baseline and day 180, five categories were reduced to two categories (none to slight versus moderate to severe). The Mc Nemar test for paired data was used to test if there was a change in nail dystrophy, discoloration, and nail thickening between baseline and day 180. A chi-square test test was performed to compare changes between both treatments in onychomycosis evolution. Note: scores are used and for this reason, no units of measure can be assigned.
Time frame: After 30, 60, 120 and 180 days of treatment
Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
Patients with positive KOH staining were included in the study. In addition, a fungal culture was performed to identify the involved species. At day 180, a new KOH staining and fungal culture was performed to evaluate the impact of each treatment on both microbiological parameters.
Time frame: At baseline (day 0) and after 180 days of treatment
Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
The investigator assigned a score from 0 (bad tolerance) to 3 (very good tolerance).
Time frame: After 30, 60, 120 and 180 days of treatment
Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.
A NailQol global score of 0 corresponds with a quality of life never altered by onychomycosis, whereas a score of 100 corresponds to a quality of life that is always affected by onychomycosis.
Time frame: After 60 and 180 days of treatment
Subject evaluation using an evaluation questionnaire, performed at each visit.
A questionnaire was included to evaluate product usability and functionality of Excilor Forte. The questionnaire was completed at each evaluation point (day 30, 60, 120, and 180, respectively). General questions were asked regarding the cosmetic effect (e.g. smoothening, brightening effect, conventional packaging..), overall satisfaction (e.g. smell, fits daily routine ...), product application (e.g. ease of application, drying time, stress-resistance, combination with top coat...), purchase intent and tolerance were asked. Subjects needed to score as follows: strongly agree, agree, neutral, disagree, strongly disagree, not concerned. Data were summarized in frequencies.
Time frame: After 30, 60, 120 and 180 days of treatment
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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