A clinical study evaluating two different nail lacquers containing cyclosporine 5% and calcipotriol 0.005% in the treatment of nail psoriasis. A placebo (no active compound) will be used as control. Nor the investigator nor the patient will know the treatment applied.
- Conditions
- ail psoriasis of the nail matrix and / or the nail bed at fingernails (at least one should be affected)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2010-019706-16-LV
- Lead Sponsor
- Polichem SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
• 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
• 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 the last 72 hours prior to study drug application until the end of the study
• Use of the following therapies for any reason during the 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 last three months before the screening visit
• Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method