Back to resultsClinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Primary Purpose
Onychomycosis of Toenail
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Solver Pen
Loceryl 5%
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail
Eligibility Criteria
Inclusion Criteria:
- Patient having given her/his informed, written consent.
- 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.
- Patient being psychologically able to understand information and to give their/his/her consent.
- Age: more than 18 years.
- 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).
- Patient with positive KOH staining.
- 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.
- 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:
- Pregnant or nursing woman or planning a pregnancy during the investigation;
- Patient considered by the Investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial during the test period.
- Subject having a known allergy to one of the constituents of the tested products.
- Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
- Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
- Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Sites / Locations
- Pr Doss office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Solver Pen
Loceryl 5%
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Microbiological efficacy: KOH staining (performance)
Evaluation of microbiological efficacy of both treatments by KOH staining on D90 versus baseline.
Microbiological efficacy: fungal culture (performance)
Evaluation of microbiological efficacy of both treatments by fungal culture on D90 versus baseline.
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)
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)
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)
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)
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)
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.
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).
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)
Incidence of Adverse events (safety and tolerability)
Collection of Adverse events and adverse device effects throughout the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961684
Brief Title
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Official Title
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
September 22, 2020 (Actual)
Study Completion Date
September 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oystershell NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solver Pen
Arm Type
Experimental
Arm Title
Loceryl 5%
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Solver Pen
Intervention Description
One application per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Loceryl 5%
Intervention Description
One application per week for 3 months
Primary Outcome Measure Information:
Title
Percentage of healthy surface (performance)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Percentage of healthy surface (performance)
Description
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.
Time Frame
30 and 60 days
Title
Microbiological efficacy: KOH staining (performance)
Description
Evaluation of microbiological efficacy of both treatments by KOH staining on D90 versus baseline.
Time Frame
90 days
Title
Microbiological efficacy: fungal culture (performance)
Description
Evaluation of microbiological efficacy of both treatments by fungal culture on D90 versus baseline.
Time Frame
90 days
Title
Clinical efficacy: onychomycosis evolution (performance)
Description
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)
Time Frame
30, 60 and 90 days
Title
Clinical efficacy: onycholysis (performance)
Description
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)
Time Frame
30, 60 and 90 days
Title
Clinical efficacy: nail distrophy (performance)
Description
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)
Time Frame
30, 60 and 90 days
Title
Clinical efficacy: nail discoloration (performance)
Description
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)
Time Frame
30, 60 and 90 days
Title
Clinical efficacy: nail thickening (performance)
Description
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)
Time Frame
30, 60 and 90 days
Title
Impact on quality of life (performance)
Description
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.
Time Frame
60 and 90 days
Title
Subjective evaluation questionnaire for the patient (performance)
Description
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).
Time Frame
14, 30, 60 and 90 days of treatment
Title
Assessment of local tolerance by the investigator (safety and tolerability)
Description
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)
Time Frame
30, 60 and 90 days
Title
Incidence of Adverse events (safety and tolerability)
Description
Collection of Adverse events and adverse device effects throughout the study
Time Frame
30, 60 and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient having given her/his informed, written consent.
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.
Patient being psychologically able to understand information and to give their/his/her consent.
Age: more than 18 years.
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).
Patient with positive KOH staining.
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.
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:
Pregnant or nursing woman or planning a pregnancy during the investigation;
Patient considered by the Investigator likely to be non-compliant with the protocol.
Patient enrolled in another clinical trial during the test period.
Subject having a known allergy to one of the constituents of the tested products.
Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nejib Doss, MD
Organizational Affiliation
Eurofins Dermscan Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pr Doss office
City
Tunis
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
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