Nail Psoriasis L40.0
Conditions
Interventions
Group 1: P-3073 (calcipotriol 0.005%) nail solution o.d. over 24 weeks
Group 2: Placebo (=Vehicle) nail solution o.d. over 24 weeks
Sponsors
Polichem SA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Written informed consent before starting any study-related procedure. • Patients aged greater or equal to 18 and less than or equal to 80 years old. • Men or women. • Outpatients. • Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score greater or equal to 1 and less than or equal to 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 less than or equal to 8% or PASI less than or equal to 10).
Exclusion criteria
Exclusion criteria: • Use of any systemic treatment for psoriasis during the last six months before the screening visit until the end of the study. • Use of photochemotherapy (phototherapy is allowed) or other forms of radiotherapy during the last four weeks before the screening visit until the end of the study. • 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 until the end of the study. • Systemic use of the following therapies for any reason during last three months before the screening visit until the end of the study: immunosuppressives, chemotherapy and corticosteroids (topical use for plaque psoriasis is allowed). • Consumption of Vitamin D or its analogues for any reason during the last three months before the screening visit. • 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 is 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 Calcipotriol 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 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 (not surgically sterile) 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: Methods that can achieve a failure rate of less than 1% per year: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal - progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable - intrauterine device (IUD) (placed at least 4 weeks prior to study drug application) - intrauterine hormone-releasing system (IUS) - bilateral tubal occlusion - sexual abstinence Methods that can achieve a failure rate of more than 1% per year: - progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action - male or female condom with or without spermicide - cap, diaphragm or sponge with spermicid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To assess the efficacy of topical P-3073 in the treatment of mild to moderate psoriatic fingernail/s (defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score greater or equal to 1 and less than or equal to 3 at baseline). Primary endpoint: The primary endpoint is the change from baseline in total NAPSI to Week 24 (end of treatment). NAPSI: To assign a score to each nail for nail bed and nail matrix psoriasis, the Nail Psoriasis Severity Index (NAPSI) will be used. The nail plate is divided into four quadrants by imaginary longitudinal and horizontal lines. Nail matrix psoriasis is assessed by the presence of any feature of nail matrix psoriasis, including nail pitting, leukonychia, red spots in the lunula, and crumbling in each quadrant of the nail. Nail bed psoriasis is assessed by the presence of any features of nail bed psoriasis, including onycholysis, oil drop (salmon patch) dyschromia, splinter haemorrhages, and nail bed hyperkeratosis in each quadrant of the nail. The score is 0 if the findings are not present, 1 if they are present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail. Thus each nail has a matrix score (0-4) and a nail bed score (0-4), and the total nail score is the sum of those two (0-8). The sum of the scores from all involved fingernails is 0-80 (total NAPSI score for that patient at that time) and represents the total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: • To assess if the topical treatment with P-3073 is able to improve the quality of life and the discomfort in patients with psoriatic fingernail. • To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail. Secondary endpoints: • Nail PGA response rate at week 24. • Change from baseline in NAPSI matrix and NAPSI bed at week 24. • Change from baseline in patient’s quality-of-life at week 24. • Change in discomfort due to fingernail psoriasis at week 24. • Proportions of nails with improvement in total NAPSI, NAPSI matrix and NAPSI bed at week 24. • Overall safety by recording any AE during the entire study duration and the tolerability after the nail solution application, by means of severity scores for skin irritation. | — |
Countries
Bulgaria, Czechia, Germany, Greece, Latvia, Poland, Russia
Contacts
Public ContactSascha Gerdes
Psoriasis-Zentrum Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel
Outcome results
None listed