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

NCT04961684 | Completed

• 1 other identifier: 19E2407
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Percentage of healthy surface (performance)

  30 and 60 days

• Microbiological efficacy: KOH staining (performance)

  90 days

• Microbiological efficacy: fungal culture (performance)

  90 days

• Clinical efficacy: onychomycosis evolution (performance)

  30, 60 and 90 days

• Clinical efficacy: onycholysis (performance)

  30, 60 and 90 days

Study Arms (2)

Solver Pen

EXPERIMENTAL

Device: Solver Pen

Loceryl 5%

ACTIVE COMPARATOR

Drug: Loceryl 5%

Interventions

Solver Pen DEVICE

One application per day for 3 months

Solver Pen

Loceryl 5% DRUG

One application per week for 3 months

Loceryl 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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…).

Sponsors & Collaborators

• Oystershell NV: lead

Study Sites (1)

Pr Doss office

Tunis, Tunisia

Location

Study Officials

• Nejib Doss, MD

  Eurofins Dermscan Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: July 14, 2021
• Study Start: February 10, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)