RecruitingPhase 3NCT07029516

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


Sponsor

Wooshin Labottach Co., Ltd.

Enrollment

72 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria7

  • 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.

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Interventions

OTHERCosmetic patch containing urea applicated daily for 3 months

Daily application of the patch on toes, 3 months treatment

OTHERPlacebo patch application

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


Locations(1)

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

Milan, Italy

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NCT07029516


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