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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Nail Psoriasis

Intervention / Treatment
-----------------
* Drug: P-3073
* Drug: Vehicle of P-3073


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nail psoriasis