An interventional study of Excilor and Loceryl 5% in Onychomycosis, sponsored by Oystershell NV. Completed at 2 sites in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-21.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" 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.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 112 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.
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.
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.
2 applications per day for 6 months
Device: Excilor
1 application per week for 6 months
Drug: Loceryl 5%
At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Time frame: After 168 days of treatment
At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Time frame: After 14, 28, 56 and 112 days of treatment
Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.
Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.
Time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.
Time frame: On baseline (day zero) and day 168
Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).
Time frame: After 14, 28, 56 and 112 days of treatment
Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.
Time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.
Time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
The record gives a start of Jan 2015, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Oystershell NV