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

NCT02606760 | Completed Phase 3

• 2 other identifiers: PM14342015-002365-34
• Study Type: interventional
• Target: 378
• Locations: 7 countries
• Sites: 7

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.

Conditions

Nail Psoriasis

Keywords

Nail psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in total Nail Psoriasis Severity Index (NAPSI)

  Baseline - Week 24

Secondary Outcomes (9)

• 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

Study Arms (2)

P-3073

EXPERIMENTAL

P-3073

Drug: P-3073

vehicle of P-3073

PLACEBO COMPARATOR

vehicle of P-3073

Drug: Vehicle of P-3073

Interventions

P-3073 DRUG

P-3073

Vehicle of P-3073 DRUG

vehicle of P-3073

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polichem S.A.: lead

Study Sites (7)

Unknown Facility

Multiple Locations, Bulgaria

Location

Unknown Facility

Multiple Locations, Czechia

Location

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Greece

Location

Unknown Facility

Multiple Locations, Latvia

Location

Unknown Facility

Multiple Locations, Poland

Location

Unknown Facility

Multiple Locations, Russia

Location

Study Officials

• Maurizio Caserini, MD

  Polichem S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 17, 2015
• Study Start: November 23, 2015
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

BU (1); GR (1); RU (1); LA (1); CZ (1); PL (1); DE (1)