NCT07029516

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Wooshin Labottach Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Nail Psoriasis
• Nail Damage
• Mycosis

Interventions

Type	Name	Description
OTHER	Cosmetic patch containing urea applicated daily for 3 months	Daily application of the patch on toes, 3 months treatment
OTHER	Placebo patch application	Daily application of a placebo patch on toes for a 3 months treatment

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-06-19
• Last updated: 2026-01-26

Locations

1 site across 1 country: Italy