The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.
This phase III study versus vehicle will be conducted to confirm the clinical efficacy and 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. The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI). The secondary objectives will be: * To assess if the topical treatment with P-3073 is able to improve the quality of life and discomfort in patients with psoriatic fingernail. * To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail. The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening. The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail. The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
Once daily for 24 weeks.
Proportion of patients with clear target nail at Week 24
Defined as Nail Psoriasis Severity Index (NAPSI) =0
Time frame: Week 24
Proportion of affected nails at baseline with NAPSI=0 at Week 24
Defined as affected nails with NAPSI=0
Time frame: Baseline - Week 24
Proportion of patients with clear target nail bed at Week 24
Defined as nail bed in NAPSI=0
Time frame: Baseline - Week 24
Proportion of patients with clear target nail matrix at Week 24
Defined as nail matrix in NAPSI=0
Time frame: Baseline - Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Polichem Investigation Site no 47
Birmingham, Alabama, United States
Polichem Investigation Site no 21
Phoenix, Arizona, United States
Polichem Investigation Site no 11
Little Rock, Arkansas, United States
Polichem Investigation Site no 45
North Hollywood, California, United States
Polichem Investigation Site no 39
San Diego, California, United States
Polichem Investigation Site no 56
Santa Monica, California, United States
Polichem Investigation Site no 18
Washington D.C., District of Columbia, United States
Polichem Investigation Site no 36
Clearwater, Florida, United States
Polichem Investigation Site no 10
Miami, Florida, United States
Polichem Investigation Site no 38
Miami, Florida, United States
...and 48 more locations