Hydrogel toe-nail patch for fragile, fungal, or psoriatic nails
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
This study will test a daily hydrogel toe-nail patch to see if it improves nail fragility, onychomycosis (fungal nails), or nail psoriasis in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wooshin Labottach Co., Ltd. Industry-sponsored |
| Locations | 1 site (Milan) |
| Trial ID | NCT07029516 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, single-center Phase 3 trial enrolling 72 adults with nail fragility, distal subungual onychomycosis, or nail psoriasis. Participants are assigned to a hydrogel nail patch containing urea or a placebo patch and instructed to apply it nightly to the affected big toe for 12 weeks. A single target nail is chosen for all efficacy assessments, with visits at screening, baseline, and weeks 3, 6, 9, and 12, plus a follow-up visit 4 weeks after treatment ends. Outcomes include photographic documentation, physician scoring, and tolerability assessments.
Who should consider this trial
Good fit: Adults aged 18 or older with a single affected big toe showing nail fragility, distal subungual onychomycosis, or nail psoriasis affecting up to 75% of the nail and who meet the trial's timing and medication washout requirements are ideal candidates.
Not a fit: Patients with proximal subungual onychomycosis, nails affected on more than 75% of the nail bed, unrelated or genetic nail disorders, immunosuppression, severe peripheral circulatory insufficiency, recent antifungal/anti-psoriasis treatments, or recent participation in other nail studies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this patch could offer a simple, topical option to improve nail strength and appearance without systemic medication.
How similar studies have performed: Prior small studies of topical urea preparations and occlusive patch approaches for nail conditions have shown mixed and limited evidence, so this specific hydrogel patch approach remains relatively novel and unproven at scale.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Adolfo Gasparetto
- Email: adolfogasparetto@nextrasearch.it
- Phone: +393356641965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.