Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-26

Study Completion Date

2017-08-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Onychomycosis of Toenail

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Excilor Forte

One application of the MD daily (at same time point), preferably after showering/bathing, during the complete study period.

Group Type EXPERIMENTAL

Excilor Forte

Intervention Type DEVICE

1 application per day during 6 months

Loceryl 5%

One application per week of the positive control Loceryl 5% during the whole study period.

Group Type ACTIVE_COMPARATOR

Loceryl 5%

Intervention Type DRUG

1 application per week during 6 months

Interventions

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Excilor Forte

1 application per day during 6 months

Intervention Type DEVICE

Loceryl 5%

1 application per week during 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject having given her/his informed, written consent.

* Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
* Subject being psychologically able to understand information and to give their/his/her consent.
* Age: more than 18 years.
* Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
* Subject with positive KOH staining.
* Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
* Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.

Exclusion Criteria

* Subject considered by the Investigator likely to be non-compliant with the protocol.
* Patient enrolled in another clinical trial during the test period.

· Woman being pregnant, nursing or planning a pregnancy during the course of this study.
* Subject having a known allergy to one of the constituents of the tested products.
* Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
* Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No