Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Device: Excilor; Drug: Loceryl 5%

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Hospital Habib Thameur
  • Tunis, Tunisia
    • Principal instruction military hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 results of 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 the 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 diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology….
• Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Excilor; 2 applications per day for 6 months	Device: Excilor
Active Comparator: Loceryl 5%; 1 application per week for 6 months	Drug: Loceryl 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 168 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.		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).		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.		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.		On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168

Collaborators and Investigators

• Sponsor: Oystershell NV
• Investigators: Principal Investigator: Nejib Doss, MD, Principal Instruction military hospital of Tunis

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Anti-Infective Agents; Antifungal Agents; Amorolfine
• Other Study ID Numbers: 14E0752

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No