Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis

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

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 Overview

• Status: Completed
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: P-3073; Drug: Vehicle of P-3073

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Multiple Locations, Bulgaria
• Czechia
  • Multiple Locations, Czechia
• Germany
  • Multiple Locations, Germany
• Greece
  • Multiple Locations, Greece
• Latvia
  • Multiple Locations, Latvia
• Poland
  • Multiple Locations, Poland
• Russian Federation
  • Multiple Locations, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent before starting any study related procedures
• Patients aged 18 to 80 years old of any race.
• Males or females.
• Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline.
• In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement ≤ 8% or PASI ≤ 10)

Exclusion Criteria:

• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Use of any systemic treatment for psoriasis during the last six months before the screening visit.
• Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit.
• Positive mycology findings
• Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit.
• Consumption of Vitamin D or its analogues during the last three months.
• History of hypercalcaemia or hypercalciuria.
• HIV infection or any other immunodeficiency.
• Alcohol or substance abuse.
• Patients with history of allergic reactions to calcipotriol or its excipients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P-3073	Drug: P-3073
Placebo Comparator: vehicle of P-3073	Drug: Vehicle of P-3073

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total Nail Psoriasis Severity Index (NAPSI)	Baseline - Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in NAPSI matrix	Baseline - Week 24
Change in NAPSI bed	Week 24
Nail Physician Global Assessment (PGA) response rate	Week 24
Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)	Baseline - Week 24
Change in discomfort by means of the Visual Analogue Scale (VAS)	Week 24
Proportions of nails with improvement in total NAPSI	Week 24
Proportions of nails with improvement in NAPSI Matrix	Week 24
Proportions of nails with improvement in NAPSI bed	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.	Week 24

Collaborators and Investigators

• Sponsor: Polichem S.A.
• Investigators: Study Director: Maurizio Caserini, MD, Polichem S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2015
• Primary Completion (Actual): February 8, 2017
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Nail psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PM1434; 2015-002365-34 (EudraCT Number)