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Recruiting Phase 3

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

NCT07029516 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2026-02
Last updated
2026-01-26

Condition(s) studied

Nail PsoriasisNail DamageMycosis

Investigational drug(s) / intervention(s)

Cosmetic patch containing urea applicated daily for 3 monthsPlacebo patch application

Cosmetic patch containing urea applicated daily for 3 months: Daily application of the patch on toes, 3 months treatment

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 — From the enrollment day (visit 1) to the follow-up visit after 4 months
    Checking of any adverse event during the treatment, and at monthly visits

Trial sites (1)

FacilityCityRegionStatus
Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029516 on ClinicalTrials.gov ↗ ← All trials in Italy