Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis

NCT06175013 | Not Yet Recruiting

• 1 other identifier: 23E2000
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical investigation is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments. The main question it aims to answer is the effectiveness of the use of a combination of two investigational devices (Sérum PURIFIANT + Sérum BOOSTER) on the percentage of healthy nail surface after 112 days of treatment. Participants will apply one or two devices on the affected toenail during the study.

• Patients included on the groupe 1 will use Sérum PURIFIANT only, twice daily.
• Patient included on group 2 will use Sérum PURIFIANT, twice daily associated with Sérum BOOSTER twice weekly. For this investigation, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Percentage of healthy surface

  The effect of the products on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using a combination of two devices (Sérum PURIFIANT + Sérum BOOSTER). Evaluation is done in blind by digital analysis of photographs of the infected toenail.

  Day 0, Day 112

Secondary Outcomes (11)

• Percentage of healthy surface in group 1

  Day 0, Day 112

• Percentage of healthy surface comparison

  Day 0, Day 112

• Onychomycosis

  Day 0, Day 112

• Onycholysis

  Day 0, Day 112

• Nail microcacking

  Day 0, Day 112

Study Arms (2)

Group 1 : Sérum Mycose des ongles PURIFIANT

EXPERIMENTAL

Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study.

Device: Sérum PURIFIANT

Group 2 : Sérum Mycose des onglesPURIANT associated with Sérum Mycose des ongles BOOSTER

EXPERIMENTAL

Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. They will also apply Sérum BOOSTER, twice weekly before the Sérum PURIFIANT.

Device: Sérum PURIFIANT in association Sérum BOOSTER

Interventions

Sérum PURIFIANT DEVICE

Application of Sérum PURIFIANT only, twice daily during 112 days

Group 1 : Sérum Mycose des ongles PURIFIANT

Sérum PURIFIANT in association Sérum BOOSTER DEVICE

Application of Sérum PURIFIANT twice daily during 112 days AND Application of Sérum BOOSTER before the Serum PURIFIANT, twice weekly

Group 2 : Sérum Mycose des onglesPURIANT associated with Sérum Mycose des ongles BOOSTER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having given freely her/his informed, written consent.
• Patient having a good general health.
• Age: more than 18 years.
• Patient cooperative and aware of the devices' 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 his/her consent.
• Patient with nails 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 slight to moderate impact of thickness of the nail and no deformation of the nail.
• Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
• Patient with positive KOH staining.
• Women of childbearing potential should use an accepted contraceptive regimen (to investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.

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.
• Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
• Patient with unstructured nail, severe microcracking or severe onycholysis.
• Patient with nails and nails contour with severe lesions
• Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
• Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth …
• Patient with cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, Hallux Valgus, Hallux rigidus, Hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis…).

Sponsors & Collaborators

• Swiss Footcare Laboratories - Poderm Professional: lead

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aslham DOARIKA

  Insight Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte BOSSON

CONTACT

+41 78 245 18 78; c.bosson@poderm.com

Emilie PIETRSZYNSKI

CONTACT

+41 78 305 67 18; e.pietrszynski@poderm.com

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: November 28, 2023
• First Posted: December 18, 2023
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share