Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis
Recruiting · NCT07029516 · Interventional (participants receive a specific treatment) · Lead sponsor: Wooshin Labottach Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Cosmetic patch containing urea applicated daily for 3 monthsPlacebo patch application
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano - Milan, Italy