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.
Full Title of Study: “A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: July 2018
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.
- Drug: P-3073 (calcipotriene 0.005%)
- Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
- Drug: Vehicle of P-3073
- Once daily for 24 weeks.
Arms, Groups and Cohorts
- Experimental: P-3073
- Placebo Comparator: Vehicle
Clinical Trial Outcome Measures
- Proportion of patients with clear target nail at Week 24
- Time Frame: Week 24
- Defined as Nail Psoriasis Severity Index (NAPSI) =0
- Proportion of affected nails at baseline with NAPSI=0 at Week 24
- Time Frame: Baseline – Week 24
- Defined as affected nails with NAPSI=0
- Proportion of patients with clear target nail bed at Week 24
- Time Frame: Baseline – Week 24
- Defined as nail bed in NAPSI=0
- Proportion of patients with clear target nail matrix at Week 24
- Time Frame: Baseline – Week 24
- Defined as nail matrix in NAPSI=0
Participating in This Clinical Trial
- Written informed consent before starting any study related procedure.
- Patients ages ≥ 18 and ≤ 80 years old.
- Men or women.
- 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).
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Polichem S.A.
- Almirall, S.A.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Maurizio Caserini, MD, Study Director, Polichem SA
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