A randomized, double-blind, vehicle-controlled, parallel-group trial to assess the efficacy, safety and tolerability of P-3073 for topical treatment of nail psoriasis
- Conditions
- ail PsoriasisL40.0Psoriasis vulgaris
- Registration Number
- DRKS00009547
- Lead Sponsor
- Polichem SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 378
• 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).
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method