study to evaluate the efficacy and safety of p-3073 nail solution in the treatment of mild to moderate psoriatic fingernail/s

Conditions: Nail Psoriasis

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.

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.

Eligibility 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.

Keywords: calcipotriene