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

Polichem S.A.

Status and phase

Completed

Phase 3

Conditions

Nail Psoriasis

Treatments

Drug: Vehicle of P-3073

Drug: P-3073

Study type

Interventional

Funder types

Industry

Identifiers

NCT02606760

PM1434

2015-002365-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

378 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.