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

NCT ID: NCT02606760

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-23
• Study Completion Date: 2017-02-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

P-3073

P-3073

Group Type: EXPERIMENTAL

P-3073

Intervention Type: DRUG

vehicle of P-3073

vehicle of P-3073

Group Type: PLACEBO_COMPARATOR

Vehicle of P-3073

Intervention Type: DRUG

Interventions

P-3073

Intervention Type: DRUG

Vehicle of P-3073

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polichem S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurizio Caserini, MD

Role: STUDY_DIRECTOR

Polichem S.A.

Locations

Multiple Locations, , Bulgaria

Multiple Locations, , Czechia

Multiple Locations, , Germany

Multiple Locations, , Greece

Multiple Locations, , Latvia

Multiple Locations, , Poland

Multiple Locations, , Russia

Countries

Bulgaria; Czechia; Germany; Greece; Latvia; Poland; Russia

Other Identifiers

2015-002365-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PM1434

Identifier Type: -

Identifier Source: org_study_id