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

Withdrawn before enrolling · Phase 3

Conditions studied: Nail Psoriasis

In brief

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.

Key facts

Study ID: NCT03079973
Run by: Polichem S.A.
People needed: 0
Starts: 2017-05-15
Expected to finish: 2018-07-01
Last updated by the study team: 2018-01-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Polichem Investigation Site no 21 — Phoenix, Arizona, United States
Polichem Investigation Site no 11 — Little Rock, Arkansas, United States
Polichem Investigation Site no 45 — North Hollywood, California, United States
Polichem Investigation Site no 39 — San Diego, California, United States
Polichem Investigation Site no 56 — Santa Monica, California, United States
Polichem Investigation Site no 18 — Washington D.C., District of Columbia, United States
Polichem Investigation Site no 36 — Clearwater, Florida, United States
Polichem Investigation Site no 10 — Miami, Florida, United States
Polichem Investigation Site no 38 — Miami, Florida, United States
Polichem Investigation Site no 13 — Miami, Florida, United States
Polichem Investigation Site no 20 — Miami Lakes, Florida, United States
Polichem Investigation Site no 17 — Ocala, Florida, United States
Polichem Investigation Site no 35 — Ormond Beach, Florida, United States
Polichem Investigation site no 1 — Tampa, Florida, United States
Polichem Investigation Site no 24 — Tampa, Florida, United States
Polichem Investigation Site no 28 — Tampa, Florida, United States
Polichem Investigation Site no 25 — Columbus, Georgia, United States
Polichem Investigation Site no 23 — Skokie, Illinois, United States
Polichem Investigation Site no 29 — West Dundee, Illinois, United States
Polichem Investigation Site no 16 — New Albany, Indiana, United States
Polichem Investigation site no 3 — West Des Moines, Iowa, United States
Polichem Investigation Site no 22 — Overland Park, Kansas, United States
Polichem Investigation Site no 52 — Louisville, Kentucky, United States
Polichem Investigation Site no 19 — Louisville, Kentucky, United States
Polichem Investigation Site no 47 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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