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Trial record 2 of 2 for:    P-3073

Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s

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ClinicalTrials.gov Identifier: NCT03079973
Recruitment Status : Withdrawn (Project development priorities changed.)
First Posted : March 15, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Polichem S.A.

Brief Summary:
The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Drug: P-3073 (calcipotriene 0.005%) Drug: Vehicle of P-3073 Phase 3

Detailed Description:

This phase III study versus vehicle will be conducted to confirm the clinical efficacy and 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.

The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI).

The secondary objectives will be:

  • To assess if the topical treatment with P-3073 is able to improve the quality of life and discomfort in patients with psoriatic fingernail.
  • To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail.

The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening.

The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail.

The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis
Estimated Study Start Date : May 15, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: P-3073 Drug: P-3073 (calcipotriene 0.005%)
Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.

Placebo Comparator: Vehicle Drug: Vehicle of P-3073
Once daily for 24 weeks.




Primary Outcome Measures :
  1. Proportion of patients with clear target nail at Week 24 [ Time Frame: Week 24 ]
    Defined as Nail Psoriasis Severity Index (NAPSI) =0


Secondary Outcome Measures :
  1. Proportion of affected nails at baseline with NAPSI=0 at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as affected nails with NAPSI=0

  2. Proportion of patients with clear target nail bed at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as nail bed in NAPSI=0

  3. Proportion of patients with clear target nail matrix at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as nail matrix in NAPSI=0


Other Outcome Measures:
  1. Proportion of patients with target nail reaching NAPSI-75% [ Time Frame: Baseline - Week 24 ]
    Defined as a reduction of ≥75% from baseline NAPSI score

  2. Proportion of affected nails at baseline reaching NAPSI-75% [ Time Frame: Baseline - Week 24 ]
    Defined as a reduction of ≥75% from baseline NAPSI score

  3. Change from Baseline in Total NAPSI at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as change in Nail Psoriasis Severity Index

  4. Time to reach NAPSI=0 in the target nail [ Time Frame: Up to Week 24 ]
    Defined as time until NAPSI=0

  5. Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as Nail PGA response rate

  6. Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as change in VAS

  7. Patient Acceptance of Study Therapy at Week 24 [ Time Frame: Baseline - Week 24 ]
    Note: Missing values will be replaced with the worst score

  8. Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as change in EQ-5D-5L

  9. Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as change in DLQI

  10. Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as change in SF-36

  11. Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24 [ Time Frame: Baseline - Week 24 ]
    Defined as change in NPQ10



Information from the National Library of Medicine

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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 procedure.
  • Patients ages ≥ 18 and ≤ 80 years old.
  • Men or women.
  • Outpatients.
  • Patients with mild to moderate psoriatic fingernail/s, defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline. The sum of the scores for each nail should range between 1 and 6.
  • In case of skin involvement, patients with established clinical diagnosis of mild to moderate psoriasis (BSA involvement ≤ 8% or Psoriasis Area Severity Index (PASI) ≤ 10).

Exclusion Criteria:

  • Use of any systemic treatment for psoriasis and/or nail psoriasis during the last six months before the screening visit.
  • Use of any topical treatment for nail psoriasis on fingernails during the last six months before the screening visit.
  • Use of photochemotherapy (phototherapy is allowed) or other forms of radiotherapy during the last four weeks before the screening visit.
  • Positive mycology findings (KOH evaluation or culture) obtained in the three months before the screening visit or positive KOH evaluated at the screening visit.
  • Patients using nail polish or other nail cosmetic products during last 72 hours prior to study drug application.
  • Systemic use of the following therapies for any reason during last three months before the screening visit: immunosuppressives, chemotherapy and corticosteroids (topical use for plaque psoriasis is allowed).
  • Consumption of oral Vitamin D or its analogues for any reason during the last three months before the screening visit (Calcipotriene topical use for plaque psoriasis is allowed).
  • Patients with a clinically significant history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction. A clinically significant disease is defined as one that in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease that may influence the results of the study or the patient's ability to participate in the study.
  • Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
  • History of hypercalcaemia or hypercalciuria.
  • History of previous or current malignancy in particular lymphoma, melanoma and/or basal cell carcinoma.
  • History of allergic reactions to Calcipotriene or P-3073 excipients.
  • Patients unable to understand the procedures and purposes of the study.
  • Patients unable or unwilling to accept and meet study requirements.
  • Use of an investigational drug or participation in an investigational study within 30 days, or 6 half lives whichever is longer, prior to application of study medication.
  • Alcohol or substance abuse.
  • AIDS symptoms or any other immunodeficiency.

Additional exclusion criteria for females only:

  • Breast-feeding patients.
  • Positive urine pregnancy test at screening (performed for all females of child bearing potential or for those in non-surgical post-menopause for less than 1 year).
  • Female of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e., a male who has not been sterilized by vasectomy at least 6 months prior to drug application) within 14 days prior to study drug application. Acceptable methods of contraception are the following: condom, diaphragm, intrauterine contraceptive device (placed at least 4 weeks prior to study drug application), pill + condom.

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): NCT03079973


  Show 58 Study Locations
Sponsors and Collaborators
Polichem S.A.
Almirall, S.A.
Investigators
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Study Director: Maurizio Caserini, MD Polichem SA

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Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT03079973     History of Changes
Obsolete Identifiers: NCT03209388
Other Study ID Numbers: PM1440
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polichem S.A.:
Calcipotriene
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents