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

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis of Toenail
• Intervention / Treatment: Device: Solver Pen; Drug: Loceryl 5%

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Pr Doss office

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:

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…).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Loceryl 5%	Drug: Loceryl 5%; One application per week for 3 months
Experimental: Solver Pen	Device: Solver Pen; One application per day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of healthy surface (performance)	Variation of the percentage of healthy surface after 90 days of treatment with the test medical device or reference versus baseline value. Evaluation is done in blind by digital analysis of photographs of the great, infected toenail.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of healthy surface (performance)	Variation of the percentage of healthy surface after 30 and 60 days of treatment with the test medical device or reference versus baseline. Blinded evaluation is performed by digital analysis of photographs of the great, infected toenail.	30 and 60 days
Microbiological efficacy: KOH staining (performance)	Evaluation of microbiological efficacy of both treatments by KOH staining on D90 versus baseline.	90 days
Microbiological efficacy: fungal culture (performance)	Evaluation of microbiological efficacy of both treatments by fungal culture on D90 versus baseline.	90 days
Clinical efficacy: onychomycosis evolution (performance)	Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of onychomycosis evolution on a 4-point scale (failure to success)	30, 60 and 90 days
Clinical efficacy: onycholysis (performance)	Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of onycholysis on a 5-point scale (none to severe)	30, 60 and 90 days
Clinical efficacy: nail distrophy (performance)	Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail distrophy on a 5-point scale (none to severe)	30, 60 and 90 days
Clinical efficacy: nail discoloration (performance)	Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail discoloration on a 5-point scale (none to severe)	30, 60 and 90 days
Clinical efficacy: nail thickening (performance)	Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail thickening on a 5-point scale (none to severe)	30, 60 and 90 days
Impact on quality of life (performance)	Evaluation of the impact on the quality of life (QoL) of the patients using a validated questionnaire (NailQoL: Nail Questionnaire Of Life from 0=no impact on life quality to 100=maximum impact on life quality) before (baseline) and 60 and 90 days of treatment with the test medical device or reference, respectively.	60 and 90 days
Subjective evaluation questionnaire for the patient (performance)	Evaluation of efficacy, tolerance, and acceptability cosmetic aspect, usability…) of the investigational device by the patients using a subjective evaluation questionnaire (answers to questions with 5 modalities from "strongly disagree" to "strongly agree"), performed at each visit and at D14 (via phone).	14, 30, 60 and 90 days of treatment
Assessment of local tolerance by the investigator (safety and tolerability)	Evaluation of local tolerance of the test medical device at each visit. Assessment is performed by the investigator via clinical evaluation and subject interrogation on a scale from 0 (bad tolerance) to 3 (very good tolerance)	30, 60 and 90 days
Incidence of Adverse events (safety and tolerability)	Collection of Adverse events and adverse device effects throughout the study	30, 60 and 90 days

Collaborators and Investigators

• Sponsor: Oystershell NV
• Investigators: Principal Investigator: Nejib Doss, MD, Eurofins Dermscan Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): September 22, 2020
• Study Completion (Actual): September 22, 2020

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

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: 19E2407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No