Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis

A Randomized, Double Blind, Placebo-controlled, Unicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of a Multi-funtion Toe Nail Patch in Patients Affected by Nail Fragility, Nail Mychosis and Psoriasis

A randomized, double blind, placebo-controlled, unicenter, parallel group study to assess the efficacy, safety and tolerability of a multi-funtion toe nail patch in patients affected by nail fragility, nail mychosis and psoriasis 72 patients in 6 subgroups Treatment duration 3 months + 1 month follow-up

Study Overview

• Status: Recruiting
• Conditions: Nail Psoriasis; Mycosis; Nail Damage
• Intervention / Treatment: Other: Cosmetic patch containing urea applicated daily for 3 months; Other: Placebo patch application

Detailed Description

A randomized, double blind, placebo-controlled, mono center, parallel group study.

72 Eligible patients will receive Hydrogel Nail Patch every day for three months, in the evening. All the patients will be characterized according to the percentage of target nail involvement (defined as either 50% or 51-75).

Patients applied their allocated treatment to the surface of all affected nails, in particular Hydrogel Nail Patch or Placebo will be applied topically in the evening at bedtime and taken away in the morning, every day for 12 (twelve)weeks. The subjects will receive a visit by the Clinical Investigator after 4 weeks from the end of treatments.

A single affected nail with Fragility nail or onychomycosis or nail psoriasis will be identified as the target nail for all assessments. Target nails had to fulfil the study's inclusion and exclusion criteria and the presence of nail pathology confirmed by Score Index test, photographic documentation, physician judgement. Patients will attend visits at screening(V0), baseline (V1), and at weeks 3(V2), 6(V3), 9(V4) and 12(V5).

The Multi-Function Toe Nail Patch and the Placebo will be applied topically on the big toe affected by nail pathology, according to their characteristics.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Adolfo Gasparetto; Phone Number: +393356641965; Email: adolfogasparetto@nextrasearch.it
• Study Contact Backup: Name: Andrea Borgatta; Phone Number: +393472644870; Email: andreaborgatta@nextrasearch.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano
    • Contact: Paolo Bortoluzzi, Phd; Phone Number: +393494182187; Email: paolo.bortoluzzi@policninico.mi.it
    • Principal Investigator: Paolo Bortoluzzi, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 18 years or older Fragility Nails Distal Subungual Onychomycosis Nail Psoriasis affecting ≤75% of the nail bed according to a photographic documentation and to a subjective evaluation by the Investigator.

Exclusion Criteria:

• Patients that have proximal subungual onychomycosis, if their distal subungual onychomycosis is extended into the proximal portion of the nail or if it affects >75% of the nail.
• Patients with conditions known to cause abnormal nail appearance, immunosuppression and signs of severe peripheral circulatory insufficiency
• Patients who had used topical antifungal, anti-psoriasis nail treatment within one month or systemic antifungal treatment within three months.
• Patients who have participated in another clinical nail study during the previous three months
• Patients who have a known allergy to any of the study treatments.
• Patients with unrelated nail disorders: onychomycosis, nail psoriasis, genetically induced onychodystrophy.
• Patients with other nail disorders, active or severe psoriasis elsewhere, other autoimmune or inflammatory diseases.

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
Placebo Comparator: Placebo; Application of the Placebo patch	Other: Placebo patch application; Daily application of a placebo patch on toes for a 3 months treatment
Experimental: EXPERIMENTAL COSMETIC; APPLICATION OF THE EXPERIMENTAL PATCH WITH COSMETIC	Other: Cosmetic patch containing urea applicated daily for 3 months; Daily application of the patch on toes, 3 months treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation, based on adverse events numeber of the Multi-Function Hydrogel Nail Patch safety in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis	Checking of any adverse event during the treatment, and at monthly visits	From the enrollment day (visit 1) to the follow-up visit after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the patch, measuring the size of the nail patology	Evaluation of the Multi-Function Hydrogel Nail Patch medical device in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis Visual improvement in clear nail at least of 50% considering the number of patients with 50% nail clearing and the rate at which the nail clearing takes place in the two treatment groups	From enrollment day (visit 1) to the follow-up visit after 4 months

Collaborators and Investigators

• Sponsor: Wooshin Labottach Co., Ltd.
• Collaborators: Nextrasearch S.r.l.s.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: June 11, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: UREA; PSORIASIS; ONICOMYCOSIS; PATCH
• Additional Relevant MeSH Terms: Infections; Skin Diseases, Papulosquamous; Skin Diseases; Bacterial Infections and Mycoses; Skin and Connective Tissue Diseases; Psoriasis; Mycoses
• Other Study ID Numbers: 2025/AFCV/WOOSHIN/MFP/PL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication
• IPD Sharing Time Frame: after the publication nontime limit
• IPD Sharing Access Criteria: TBDefined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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