Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment

NCT06254027 | Unknown

• 1 other identifier: 23E3473
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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.

  270 days

Secondary Outcomes (7)

• Percentage of healthy surface (Performance)

  30 days; 90 days; 180 days

• Microbiological efficacy: KOH staining (Performance)

  270 days (month 9)

• Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)

  Baseline, 30 days; 90 days, 180 days; 270 days

• Clinical efficacy: onychomycosis evolution (Performance)

  30 days; 90 days; 180 days; 270 days

• Impact on quality of life (Performance)

  Baseline, 30 days; 90 days, 180 days; 270 days

Study Arms (3)

Forte

EXPERIMENTAL

Device: One application per day for 9 months.

Device: Forte

Active Cover Light

EXPERIMENTAL

Device: One application per day for 9 months.

Device: Active Cover Light

Loceryl 5%

ACTIVE COMPARATOR

Drug: Loceryl 5% One application per week for 3 months

Drug: Loceryl

Interventions

Forte DEVICE

One application per day for a complete treatment period.

Also known as: Excilor

Forte

Active Cover Light DEVICE

One application per day for a complete treatment period.

Also known as: Nailner

Active Cover Light

Loceryl DRUG

One application per week for a complete treatment period.

Also known as: Amorolfine

Loceryl 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having given freely her/his informed, written consent.
• Patient having a good general health.
• Age: more than 18 years.
• Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablets).
• Patient with positive KOH staining.
• Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
• Patient being psychologically able to understand information and to give their/his/her consent.
• Patient having stopped any systemic antifungal treatment since at least 6 months before screening.
• Patient having stopped any topical antifungal treatment since at least 3 months before screening.
• Patient who agrees to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.
• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.

You may not qualify if:

• Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
• Patient considered by the investigator likely to be non-compliant with the protocol.
• Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
• Patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
• Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
• Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Sponsors & Collaborators

• Oystershell NV: lead
• Eurofins: collaborator

MeSH Terms

Conditions

Onychomycosis

Interventions

amorolfine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-01