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WithdrawnNCT03079973Updated Jan 10, 2018

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

A Phase 3 interventional study of P-3073 (calcipotriene 0.005%) and Vehicle of P-3073 in Nail Psoriasis, sponsored by Polichem S.A.. Withdrawn at 58 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Polichem S.A. · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Project development priorities changed.
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nail Psoriasis

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Keywords

  • Calcipotriene
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

Browse Psoriasis studies →

Lead sponsor

Polichem S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    P-3073

    Drug: P-3073 (calcipotriene 0.005%)

  • Placebo comparator
    Vehicle

    Drug: Vehicle of P-3073

Interventions

  • DrugP-3073 (calcipotriene 0.005%)

    Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.

  • DrugVehicle of P-3073

    Once daily for 24 weeks.

06

What researchers measure

Primary outcomes

  1. Proportion of patients with clear target nail at Week 24

    Defined as Nail Psoriasis Severity Index (NAPSI) =0

    Time frame: Week 24

Secondary outcomes

  1. Proportion of affected nails at baseline with NAPSI=0 at Week 24

    Defined as affected nails with NAPSI=0

    Time frame: Baseline - Week 24

  2. Proportion of patients with clear target nail bed at Week 24

    Defined as nail bed in NAPSI=0

    Time frame: Baseline - Week 24

  3. Proportion of patients with clear target nail matrix at Week 24

    Defined as nail matrix in NAPSI=0

    Time frame: Baseline - Week 24

Other outcomes

  1. Proportion of patients with target nail reaching NAPSI-75%

    Defined as a reduction of ≥75% from baseline NAPSI score

    Time frame: Baseline - Week 24

  2. Proportion of affected nails at baseline reaching NAPSI-75%

    Defined as a reduction of ≥75% from baseline NAPSI score

    Time frame: Baseline - Week 24

  3. Change from Baseline in Total NAPSI at Week 24

    Defined as change in Nail Psoriasis Severity Index

    Time frame: Baseline - Week 24

  4. Time to reach NAPSI=0 in the target nail

    Defined as time until NAPSI=0

    Time frame: Up to Week 24

  5. Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24

    Defined as Nail PGA response rate

    Time frame: Baseline - Week 24

  6. Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24

    Defined as change in VAS

    Time frame: Baseline - Week 24

  7. Patient Acceptance of Study Therapy at Week 24

    Note: Missing values will be replaced with the worst score

    Time frame: Baseline - Week 24

  8. Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24

    Defined as change in EQ-5D-5L

    Time frame: Baseline - Week 24

  9. Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24

    Defined as change in DLQI

    Time frame: Baseline - Week 24

  10. Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24

    Defined as change in SF-36

    Time frame: Baseline - Week 24

  11. Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24

    Defined as change in NPQ10

    Time frame: Baseline - Week 24

07

Study locations

58 sites
  • Polichem Investigation Site no 47
    Birmingham, Alabama 35233, United States
  • Polichem Investigation Site no 21
    Phoenix, Arizona 85032, United States
  • Polichem Investigation Site no 11
    Little Rock, Arkansas 72204, United States
  • Polichem Investigation Site no 45
    North Hollywood, California 91606, United States
  • Polichem Investigation Site no 39
    San Diego, California 92123, United States
  • Polichem Investigation Site no 56
    Santa Monica, California 90404, United States
  • Polichem Investigation Site no 18
    Washington, District of Columbia 20037, United States
  • Polichem Investigation Site no 36
    Clearwater, Florida 33757, United States
  • Polichem Investigation Site no 20
    Miami Lakes, Florida 33016, United States
  • Polichem Investigation Site no 10
    Miami, Florida 33134, United States
  • Polichem Investigation Site no 38
    Miami, Florida 33136, United States
  • Polichem Investigation Site no 13
    Miami, Florida 33175, United States
  • Polichem Investigation Site no 17
    Ocala, Florida 34471, United States
  • Polichem Investigation Site no 35
    Ormond Beach, Florida 32174, United States
  • Polichem Investigation site no 1
    Tampa, Florida 33607, United States
  • Polichem Investigation Site no 24
    Tampa, Florida 33612, United States
  • Polichem Investigation Site no 28
    Tampa, Florida 33624, United States
  • Polichem Investigation Site no 25
    Columbus, Georgia 31904, United States
  • Polichem Investigation Site no 23
    Skokie, Illinois 60077, United States
  • Polichem Investigation Site no 29
    West Dundee, Illinois 60118, United States
  • Polichem Investigation Site no 16
    New Albany, Indiana 47150, United States
  • Polichem Investigation site no 3
    West Des Moines, Iowa 50265, United States
  • Polichem Investigation Site no 22
    Overland Park, Kansas 66215, United States
  • Polichem Investigation Site no 52
    Louisville, Kentucky 40202, United States
  • Polichem Investigation Site no 19
    Louisville, Kentucky 40241, United States
  • Polichem Investigation Site no 49
    New Orleans, Louisiana 70112, United States
  • Polichem Investigation Site no 32
    New Orleans, Louisiana 70115, United States
  • Polichem Investigation Site no 34
    Rockville, Maryland 20850, United States
  • Polichem Investigation Site no 31
    Ann Arbor, Michigan 48109, United States
  • Polichem Investigation Site no 2
    Bay City, Michigan 47706, United States
  • Polichem Investigation Site no 9
    Fridley, Minnesota 55432, United States
  • Polichem Investigation Site no 6
    Omaha, Nebraska 68134, United States
  • Polichem Investigation Site no 5
    Las Vegas, Nevada 89148, United States
  • Polichem Investigation Site no 41
    Portsmouth, New Hampshire 03801, United States
  • Polichem Investigation Site no 58
    East Windsor, New Jersey 08520, United States
  • Polichem Investigation Site no 54
    Buffalo, New York 14221, United States
  • Polichem Investigation Site no 37
    New York, New York 10029, United States
  • Polichem Investigation Site no 4
    Rochester, New York 14609, United States
  • Polichem Investigation Site no 48
    Rochester, New York 14623, United States
  • Polichem Investigation Site no 46
    High Point, North Carolina 27262, United States
  • Polichem Investigation Site no 27
    Winston-Salem, North Carolina 27104, United States
  • Polichem Investigation Site no 44
    Cincinnati, Ohio 45249, United States
  • Polichem Investigation Site no 40
    Norman, Oklahoma 71071, United States
  • Polichem Investigation Site no 14
    Portland, Oregon 97239, United States
  • Polichem Investigation Site no 51
    Johnston, Rhode Island 02919, United States
  • Polichem Investigation Site no 8
    Charleston, South Carolina 29401, United States
  • Polichem Investigation Site no 26
    Rapid City, South Dakota 57702, United States
  • Polichem Investigation Site no 12
    Goodlettsville, Tennessee 37072, United States
  • Polichem Investigation Site no 7
    Knoxville, Tennessee 37922, United States
  • Polichem Investigation Site no 56
    Arlington, Texas 76011, United States
  • Polichem Investigation Site no 43
    Dallas, Texas 75246, United States
  • Polichem Investigation Site no 42
    Pflugerville, Texas 78660, United States
  • Polichem Investigation Site no 33
    San Antonio, Texas 78213, United States
  • Polichem Investigation Site no 53
    San Antonio, Texas 78229, United States
  • Polichem Investigation Site no 55
    San Antonio, Texas 78249, United States
  • Polichem Investigation Site no 50
    Murray, Utah 84107, United States
  • Polichem Investigation Site no 15
    Norfolk, Virginia 23502, United States
  • Polichem Investigation Site no 30
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03079973
Lead sponsor
Polichem S.A.
Collaborators
Almirall, S.A.
Responsible party
Sponsor
First posted
Mar 15, 2017
Start date
May 15, 2017 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Jan 10, 2018

Study contacts

Maurizio Caserini, MD
study director · Polichem SA

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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