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

NCT ID: NCT04961684

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2020-09-22

Brief Summary

The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.

Conditions

Onychomycosis of Toenail

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Solver Pen

Group Type: EXPERIMENTAL

Solver Pen

Intervention Type: DEVICE

One application per day for 3 months

Loceryl 5%

Group Type: ACTIVE_COMPARATOR

Loceryl 5%

Intervention Type: DRUG

One application per week for 3 months

Interventions

Solver Pen

One application per day for 3 months

Intervention Type: DEVICE

Loceryl 5%

One application per week for 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient having given her/his informed, written consent.

2. Patient 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.

3. Patient being psychologically able to understand information and to give their/his/her consent.

4. Age: more than 18 years.

5. 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).

6. Patient with positive KOH staining.

7. Patient 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.

8. Women 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

1. Pregnant or nursing woman or planning a pregnancy during the investigation;

2. Patient considered by the Investigator likely to be non-compliant with the protocol.

3. Patient enrolled in another clinical trial during the test period.

4. Subject having a known allergy to one of the constituents of the tested products.

5. Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;

6. Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…

7. 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

Sponsors

Oystershell NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nejib Doss, MD

Role: PRINCIPAL_INVESTIGATOR

Eurofins Dermscan Tunisia

Locations

Pr Doss office

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

19E2407

Identifier Type: -

Identifier Source: org_study_id