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

Purpose

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.

Condition	Intervention	Phase
Nail Psoriasis	Drug: P-3073 Drug: Vehicle of P-3073	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Polichem S.A.:

Primary Outcome Measures:

Change in total Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Baseline - Week 24 ]

Secondary Outcome Measures:

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


Enrollment:	378
Actual Study Start Date:	November 23, 2015
Study Completion Date:	February 8, 2017
Primary Completion Date:	February 8, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: P-3073 P-3073	Drug: P-3073
Placebo Comparator: vehicle of P-3073 vehicle of P-3073	Drug: Vehicle of P-3073

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02606760

Locations


Bulgaria

Various cities, Bulgaria
Czechia

Various cities, Czechia
Germany

Various cities, Germany
Greece

Various cities, Greece
Latvia

Various cities, Latvia
Poland

Various cities, Poland
Russian Federation

Various cities, Russian Federation

Sponsors and Collaborators

Polichem S.A.

Investigators


Study Director:	Maurizio Caserini, MD	Polichem S.A.

More Information


Responsible Party:	Polichem S.A.
ClinicalTrials.gov Identifier:	NCT02606760 History of Changes
Other Study ID Numbers:	PM1434 2015-002365-34 ( EudraCT Number )
Study First Received:	November 11, 2015
Last Updated:	May 17, 2017

Keywords provided by Polichem S.A.:


Nail psoriasis

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases

ClinicalTrials.gov processed this record on July 17, 2017