Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWooshin Labottach Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cosmetic patch containing urea applicated daily for 3 months
- Placebo patch application
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wooshin Labottach Co., Ltd.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator
Source ClinicalTrials.gov