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

NCT07029516 | Recruiting Phase 3

• 1 other identifier: 2025/AFCV/WOOSHIN/MFP/PL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nail Damage; Mycosis; Nail Psoriasis

Keywords

ONICOMYCOSIS; PATCH; UREA; PSORIASIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of the patch, measuring the size of the nail patology

  From enrollment day (visit 1) to the follow-up visit after 4 months

Study Arms (2)

EXPERIMENTAL COSMETIC

EXPERIMENTAL

APPLICATION OF THE EXPERIMENTAL PATCH WITH COSMETIC

Other: Cosmetic patch containing urea applicated daily for 3 months

Placebo

PLACEBO COMPARATOR

Application of the Placebo patch

Other: Placebo patch application

Interventions

Placebo patch application OTHER

Daily application of a placebo patch on toes for a 3 months treatment

Placebo

Cosmetic patch containing urea applicated daily for 3 months OTHER

Daily application of the patch on toes, 3 months treatment

EXPERIMENTAL COSMETIC

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wooshin Labottach Co., Ltd.: lead
• Nextrasearch S.r.l.s.: collaborator

Study Sites (1)

Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Mycoses; Psoriasis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Adolfo Gasparetto

CONTACT

+393356641965; adolfogasparetto@nextrasearch.it

Andrea Borgatta

CONTACT

+393472644870; andreaborgatta@nextrasearch.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: ANONIMIZATION
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 6 GROUPS (3 PATOLOGIES ONE EXPERIMENTAL, ONE PLACEBO)

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: after the publication nontime limit
• Access Criteria: TBDefined

Locations

IT (1)