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

Phase 3

Completed

• Conditions: Nail Psoriasis
• Interventions: Drug: Vehicle of P-3073; Drug: P-3073

• Registration Number: NCT02606760
• Lead Sponsor: Polichem S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Study Start: 2015-11-23
• Primary Completion: 2017-02-08
• Study Completion: 2017-02-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vehicle of P-3073	Vehicle of P-3073	vehicle of P-3073
P-3073	P-3073	P-3073

Primary Outcome Measures

Name	Time	Method
Change in total Nail Psoriasis Severity Index (NAPSI)	Baseline - Week 24

Secondary Outcome Measures

Name	Time	Method
Change in NAPSI bed	Week 24
Proportions of nails with improvement in total NAPSI	Week 24
Nail Physician Global Assessment (PGA) response rate	Week 24
Proportions of nails with improvement in NAPSI Matrix	Week 24
Change in NAPSI matrix	Baseline - 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.	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
Proportions of nails with improvement in NAPSI bed	Week 24