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Clinical Trials/NCT02606760
NCT02606760CompletedPhase 3

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

Polichem S.A.0 sites378 target enrollmentStarted: November 23, 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
378
Primary Endpoint
Change in total Nail Psoriasis Severity Index (NAPSI)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

P-3073

Experimental

P-3073

Intervention: P-3073 (Drug)

vehicle of P-3073

Placebo Comparator

vehicle of P-3073

Intervention: Vehicle of P-3073 (Drug)

Outcomes

Primary Outcomes

Change in total Nail Psoriasis Severity Index (NAPSI)

Time Frame: Baseline - Week 24

Secondary Outcomes

  • 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)

Investigators

Sponsor
Polichem S.A.
Sponsor Class
Industry
Responsible Party
Sponsor

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