The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild to moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
378
Unnamed facility
Multiple Locations, Bulgaria
Unnamed facility
Multiple Locations, Czechia
Unnamed facility
Multiple Locations, Germany
Unnamed facility
Multiple Locations, Greece
Unnamed facility
Change in total Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline - Week 24
Change in NAPSI matrix
Time frame: Baseline - Week 24
Change in NAPSI bed
Time frame: Week 24
Nail Physician Global Assessment (PGA) response rate
Time frame: Week 24
Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)
Time frame: Baseline - Week 24
Change in discomfort by means of the Visual Analogue Scale (VAS)
Time frame: Week 24
Proportions of nails with improvement in total NAPSI
Time frame: Week 24
Proportions of nails with improvement in NAPSI Matrix
Time frame: Week 24
Proportions of nails with improvement in NAPSI bed
Time frame: Week 24
Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
Time frame: Week 24
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Multiple Locations, Latvia
Unnamed facility
Multiple Locations, Poland
Unnamed facility
Multiple Locations, Russia