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Completed

NCT Number: NCT02606760

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multiple Locations, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P-3073

Drug

Vehicle of P-3073

Drug

Primary outcomes

  1. Change in total Nail Psoriasis Severity Index (NAPSI)

    Time frame: Baseline - Week 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Polichem S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2015
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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