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

Primary Purpose

Nail Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

P-3073

Vehicle of P-3073

About this trial

This is an interventional treatment trial for Nail Psoriasis focused on measuring Nail psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

P-3073

vehicle of P-3073

Arm Description

P-3073

vehicle of P-3073

Outcomes

Primary Outcome Measures

Change in total Nail Psoriasis Severity Index (NAPSI)

Secondary Outcome Measures

Change in NAPSI matrix

Change in NAPSI bed

Nail Physician Global Assessment (PGA) response rate

Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)

Change in discomfort by means of the Visual Analogue Scale (VAS)

Proportions of nails with improvement in total NAPSI

Proportions of nails with improvement in NAPSI Matrix

Proportions of nails with improvement in NAPSI bed

Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.

Full Information

NCT ID

NCT02606760

First Posted

November 11, 2015

Last Updated

March 6, 2018

Sponsor

Polichem S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02606760

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

November 23, 2015 (Actual)

Primary Completion Date

February 8, 2017 (Actual)

Study Completion Date

February 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polichem S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nail Psoriasis

Keywords

Nail psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

378 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P-3073

Arm Type

Experimental

Arm Description

P-3073

Arm Title

vehicle of P-3073

Arm Type

Placebo Comparator

Arm Description

vehicle of P-3073

Intervention Type

Drug

Intervention Name(s)

P-3073

Intervention Type

Drug

Intervention Name(s)

Vehicle of P-3073

Primary Outcome Measure Information:

Title

Change in total Nail Psoriasis Severity Index (NAPSI)

Time Frame

Baseline - Week 24

Secondary Outcome Measure Information:

Title

Change in NAPSI matrix

Time Frame

Baseline - Week 24

Title

Change in NAPSI bed

Time Frame

Week 24

Title

Nail Physician Global Assessment (PGA) response rate

Time Frame

Week 24

Title

Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)

Time Frame

Baseline - Week 24

Title

Change in discomfort by means of the Visual Analogue Scale (VAS)

Time Frame

Week 24

Title

Proportions of nails with improvement in total NAPSI

Time Frame

Week 24

Title

Proportions of nails with improvement in NAPSI Matrix

Time Frame

Week 24

Title

Proportions of nails with improvement in NAPSI bed

Time Frame

Week 24

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurizio Caserini, MD

Organizational Affiliation

Polichem S.A.

Official's Role

Study Director

Facility Information:

City

Multiple Locations

Country

Bulgaria

City

Multiple Locations

Country

Czechia

City

Multiple Locations

Country

Germany

City

Multiple Locations

Country

Greece

City

Multiple Locations

Country

Latvia

City

Multiple Locations

Country

Poland

City

Multiple Locations

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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