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

• Status: Completed
• Trial end date: 2017-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polichem S.A.

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.