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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254027
• Other study ID #: 23E3473
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Oystershell NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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…).

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• Forte
One application per day for a complete treatment period.
• Active Cover Light
One application per day for a complete treatment period.

Drug:
• Loceryl
One application per week for a complete treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oystershell NV	Eurofins

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of healthy surface (Performance)	Variation of the percentage of healthy nail surface versus baseline value.	30 days; 90 days; 180 days
Secondary	Microbiological efficacy: KOH staining (Performance)	Evaluation of microbiological efficacy versus baseline by KOH staining and fungal culture.	270 days (month 9)
Secondary	Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)	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
Secondary	Clinical efficacy: onychomycosis evolution (Performance)	Assessment of onychomycosis evolution by the investigator in live by scoring: - Failure: increase in the total infected area or aggravation; - Status Quo; - Improvement: decrease of the total infected area; - Success: Disappearance of the total infected area	30 days; 90 days; 180 days; 270 days
Secondary	Impact on quality of life (Performance)	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
Secondary	Subjective evaluation questionnaire for the patient (Performance)	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
Secondary	Evaluation of tolerance	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