Clinical trial NCT02606760: Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
Official title: A Randomized, Double-blind, Vehicle-controlled, Parallel Group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nail Psoriasis
Keywords: Nail psoriasis
Lead sponsor: Polichem S.A.
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in total Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline - Week 24
Secondary outcomes:
measure: Change in NAPSI matrix
timeFrame: Baseline - Week 24
measure: Change in NAPSI bed
timeFrame: Week 24
measure: Nail Physician Global Assessment (PGA) response rate
timeFrame: Week 24
measure: Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline - Week 24
measure: Change in discomfort by means of the Visual Analogue Scale (VAS)
timeFrame: Week 24
measure: Proportions of nails with improvement in total NAPSI
timeFrame: Week 24
measure: Proportions of nails with improvement in NAPSI Matrix
timeFrame: Week 24
measure: Proportions of nails with improvement in NAPSI bed
timeFrame: Week 24
measure: Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
timeFrame: Week 24
Other outcomes:
Locations:
city: Multiple Locations
country: Bulgaria
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Greece
city: Multiple Locations
country: Latvia
city: Multiple Locations
country: Poland
city: Multiple Locations
country: Russian Federation
Study officials:
affiliation: Polichem S.A.
name: Maurizio Caserini, MD
role: STUDY_DIRECTOR
References: