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

February 9, 2024 updated by: Oystershell NV

Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to evaluate the effectiveness of FORTE (X92001873), ACTIVE COVER LIGHT (X92001872) and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.

The secondary objectives are to evaluate:

  • Their effectiveness in the treatment of onychomycosis based on the microbiological cure (KOH staining and fungal culture)
  • Their effectiveness in the improvement of nail appearance (onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening)
  • Their effectiveness in the improvement of the quality of life of the patients using a specific questionnaire.
  • Their effectiveness, tolerance and acceptability based on patient's opinion.
  • Their safety The aim of the study is to demonstrate non-inferiority of the change in healthy nail surface from baseline to D270 of each product (μD) versus a predefined limit of 16% (clinically meaningful: μC) with a non-inferiority margin of δ = -5%

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patient having given freely her/his informed, written consent.
  2. Patient having a good general health.
  3. Age: more than 18 years.
  4. 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).
  5. Patient with positive KOH staining.
  6. 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.
  7. Patient being psychologically able to understand information and to give their/his/her consent.
  8. Patient having stopped any systemic antifungal treatment since at least 6 months before screening.
  9. Patient having stopped any topical antifungal treatment since at least 3 months before screening.
  10. 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.
  11. 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.

Exclusion Criteria:

  1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
  2. Patient considered by the investigator likely to be non-compliant with the protocol.
  3. Patient enrolled in another clinical trial or which exclusion period is not over.
  4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
  5. 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…
  6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
  7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Forte

Device:

One application per day for 9 months.
Device: Forte
One application per day for a complete treatment period.
Other Names:
  • Excilor
Experimental: Active Cover Light

Device:

One application per day for 9 months.
Device: Active Cover Light
One application per day for a complete treatment period.
Other Names:
  • Nailner
Active Comparator: Loceryl 5%
Drug: Loceryl 5% One application per week for 3 months
Drug: Loceryl
One application per week for a complete treatment period.
Other Names:
  • Amorolfine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of healthy surface (Performance)
Time Frame: 270 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of healthy surface (Performance)
Time Frame: 30 days; 90 days; 180 days
Variation of the percentage of healthy nail surface versus baseline value.
30 days; 90 days; 180 days
Microbiological efficacy: KOH staining (Performance)
Time Frame: 270 days (month 9)
Evaluation of microbiological efficacy versus baseline by KOH staining and fungal culture.
270 days (month 9)
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Time Frame: Baseline, 30 days; 90 days, 180 days; 270 days

Evaluation of the visual appearance of the nail by assessing following parameters: onycholysis, nail dystrophy, nail discoloration, and nail thickening by the investigator in live.

Each parameter is scored from 0 (none) - 4 (severe). The total score of all parameters is an indication of the visual appearance of the nail.
Baseline, 30 days; 90 days, 180 days; 270 days
Clinical efficacy: onychomycosis evolution (Performance)
Time Frame: 30 days; 90 days; 180 days; 270 days

Assessment of onychomycosis evolution by the investigator in live by scoring:

  1. - Failure: increase in the total infected area or aggravation
  2. - Status Quo
  3. - Improvement: decrease of the total infected area
  4. - Success: Disappearance of the total infected area
30 days; 90 days; 180 days; 270 days
Impact on quality of life (Performance)
Time Frame: Baseline, 30 days; 90 days, 180 days; 270 days

Evaluation of the impact on the quality of life (QoL) of patients using a validated questionnaire (NailQoL).

The questionnaire contains 15 questions, each using the scoring:

  • 0 (never)
  • 25 (rarely)
  • 50 (sometimes)
  • 75 (often)
  • 100 (all the time)
Baseline, 30 days; 90 days, 180 days; 270 days
Subjective evaluation questionnaire for the patient (Performance)
Time Frame: 14 days; 30 days; 90 days; 180 days; 270 days

Evaluation of efficacy, tolerance, and acceptability of the test medical devices and reference by the patients using a subjective evaluation questionnaire.

The subjective evaluation questionnaire uses a scoring (Completely Agree, Agree, Neutral, Disagree or Completely disagree) or uses 'Yes/No'- questions to be able to provide a score for performance.

Some open questions are added to allow the patients to elaborate on certain answers in order to have a better understanding of their response.
14 days; 30 days; 90 days; 180 days; 270 days
Evaluation of tolerance
Time Frame: 30 days; 90 days; 180 days; 270 days
Evaluation of tolerance of the test medical devices and reference. Assessment is performed by the investigator via clinical evaluation and subject interrogation. The investigator will assign a score between 0 (bad tolerance) to 3 (very good tolerance).
30 days; 90 days; 180 days; 270 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oystershell NV

Collaborators

Eurofins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23E3473

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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