Hydrogel toe-nail patch for fragile, fungal, or psoriatic nails
Official title: 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
Run by Wooshin Labottach Co., Ltd. · NCT07029516 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Wooshin Labottach Co., Ltd. Industry-sponsored |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | February 2026 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07029516 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.