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

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ClinicalTrials.gov Identifier: NCT02606760
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Drug: P-3073 Drug: Vehicle of P-3073 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2015
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : February 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: P-3073
P-3073
Drug: P-3073
Placebo Comparator: vehicle of P-3073
vehicle of P-3073
Drug: Vehicle of P-3073



Primary Outcome Measures :
  1. Change in total Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Baseline - Week 24 ]

Secondary Outcome Measures :
  1. Change in NAPSI matrix [ Time Frame: Baseline - Week 24 ]
  2. Change in NAPSI bed [ Time Frame: Week 24 ]
  3. Nail Physician Global Assessment (PGA) response rate [ Time Frame: Week 24 ]
  4. Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline - Week 24 ]
  5. Change in discomfort by means of the Visual Analogue Scale (VAS) [ Time Frame: Week 24 ]
  6. Proportions of nails with improvement in total NAPSI [ Time Frame: Week 24 ]
  7. Proportions of nails with improvement in NAPSI Matrix [ Time Frame: Week 24 ]
  8. Proportions of nails with improvement in NAPSI bed [ Time Frame: Week 24 ]
  9. Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. [ Time Frame: Week 24 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606760


Locations
Bulgaria
Multiple Locations, Bulgaria
Czechia
Multiple Locations, Czechia
Germany
Multiple Locations, Germany
Greece
Multiple Locations, Greece
Latvia
Multiple Locations, Latvia
Poland
Multiple Locations, Poland
Russian Federation
Multiple Locations, Russian Federation
Sponsors and Collaborators
Polichem S.A.
Investigators
Study Director: Maurizio Caserini, MD Polichem S.A.

Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT02606760     History of Changes
Other Study ID Numbers: PM1434
2015-002365-34 ( EudraCT Number )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Keywords provided by Polichem S.A.:
Nail psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases