Nail psoriasis MedDRA version: 9.1 Level: LLT Classification code 10028703
Conditions
Interventions
Product Code: P-3072
Pharmaceutical Form: Cutaneous solution
CAS Number: 59865-13-3
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form o
Sponsors
POLICHEM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent before starting any study related procedures • Patients aged = 18 and = 80 years old • Males or females • Outpatients • Patients with established clinical diagnosis of mild to moderate psoriasis (BSA involvement = 10% or PASI = 10) having nail psoriasis (fingernails) of the nail matrix and /or the nail bed affecting at least one nail • Presence of at least one clinical sign of nail psoriasis of the matrix (pitting, leukonychia, red spots in lunula, nail plate crumbling) and/or of the nail bed (salmon patch, onycholysis, hyperkeratosis and splinter hemorrhage) in at least one nail Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Clinical diagnosis of psoriasis for less than six months •Use of any systemic treatment for psoriasis during the last six months before the screening visit until the end of the study •Use of photochemotheraphy (phototherapy is permitted) 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 •Use of the following therapies for any reason during last three months before the screening visit until the end of the study: immunosuppressive, chemotherapy and corticosteroids •Assumption of Vitamin D or its analogues for any reason during the last three months before the screening visit •Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which 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 nephropathy or serum creatinine, urate or potassium levels more than twice above the upper limit of reference range •History of viral hepatitis B or C or AST, ALT and ?GT levels more than twice above the upper limit of reference range •History of previous or current malignancy in particular lymphoma, melanoma and basal cell carcinoma •History of allergic reactions to Cyclosporine or P-3072 excipients •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 to all females of child bearing potential or being 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. 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 Exclusion criteria during the study: •Any systemic treatment for psoriasis •Any topical product on nails (cosmetic or local treatment for nail psoriasis) •Use of the following therapies: immunosuppressive, chemotherapy, corticosteroids, vitamin D or its analogues •Evidence of pregnancy will lead the treatment to be stopped and pregnancy outcome followed up until delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the changes of clinical signs of nail bed and of the nail matrix of the nails affected by psoriasis by means of NAPSI score at the end of treatment, at each study visit and at the follow-up visit (12 weeks after the end of treatment) •To evaluate the changes of nail thickness of the affected nails by means of 20 MHz ultrasound at the end of treatment, at each study visit and at the end of the follow-up up period (12 weeks after the end of treatment) •Evaluation of the safety profile of P-3072 and P-3073 at the end of treatment and at each study visit by means of AE monitoring •To evaluate the changes in patient’s quality of life at the end of treatment, at each study visit and at the end of the follow-up period (12 weeks after the end of treatment) •To evaluate the changes in pain due to nail psoriasis •To evaluate the changes in discomfort due to nail psoriasis •To evaluate patient’s opinion on the product (effectiveness and acceptability) at the end of treatment;Secondary Objective: not applicable;Primary end point(s): •Changes in clinical signs of the nail bed (salmon patch, onycholysis, hyperkeratosis and splinter hemorrhage) and of the nail matrix (pitting, leukonychia, red spots in lunula, nail plate crumbling) of the affected nails evaluated by means of NAPSI score at the end of treatment, at each study visit and at the follow-up visit •Changes of nail thickness of the affected nails evaluated by means of 20 MHz ultrasound at the end of treatment, at each study visit and at the end of the follow-up period •Evaluation of the safety profile of P-3072 and P-3073 at each study visit by means of AE monitoring •Changes in patient’s quality of life by means of NPQ10 (Nail Psoriasis Quality of Life) and DLQI (Dermatology Life Quality Index) questionnaires evaluated at each study visit •Changes of pain due to nail psoriasis by means of a VAS (Visual Analogue Scale) •Changes of discomfort due to nail psoriasis by means of a VAS (Visua | — |
Countries
Italy, Latvia
Outcome results
None listed