NCT03079973

Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s

A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Polichem S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nail Psoriasis

Interventions

Type	Name	Description
DRUG	P-3073 (calcipotriene 0.005%)	Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
DRUG	Vehicle of P-3073	Once daily for 24 weeks.

Timeline

• Start date: 2017-05-15
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2017-03-15
• Last updated: 2018-01-10

Locations

58 sites across 1 country: United States

Regulatory

• FDA-regulated drug study