Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis
Recruiting
Phase 3Interventional Study
Nail PsoriasisNail DamageMycosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Wooshin Labottach Co., Ltd. · Industry
Who this trial is looking for
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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
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Eligibility 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 onych…
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.
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