Clinical trial NCT04961684: 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
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis of Toenail
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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...).

Primary outcomes:
measure: Percentage of healthy surface (performance)
timeFrame: 90 days
Secondary outcomes:
measure: Percentage of healthy surface (performance)
timeFrame: 30 and 60 days
measure: Microbiological efficacy: KOH staining (performance)
timeFrame: 90 days
measure: Microbiological efficacy: fungal culture (performance)
timeFrame: 90 days
measure: Clinical efficacy: onychomycosis evolution (performance)
timeFrame: 30, 60 and 90 days
measure: Clinical efficacy: onycholysis (performance)
timeFrame: 30, 60 and 90 days
measure: Clinical efficacy: nail distrophy (performance)
timeFrame: 30, 60 and 90 days
measure: Clinical efficacy: nail discoloration (performance)
timeFrame: 30, 60 and 90 days
measure: Clinical efficacy: nail thickening (performance)
timeFrame: 30, 60 and 90 days
measure: Impact on quality of life (performance)
timeFrame: 60 and 90 days
measure: Subjective evaluation questionnaire for the patient (performance)
timeFrame: 14, 30, 60 and 90 days of treatment
measure: Assessment of local tolerance by the investigator (safety and tolerability)
timeFrame: 30, 60 and 90 days
measure: Incidence of Adverse events (safety and tolerability)
timeFrame: 30, 60 and 90 days
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Pr Doss office
Study officials:
affiliation: Eurofins Dermscan Tunisia
name: Nejib Doss, MD
role: PRINCIPAL_INVESTIGATOR
References: