Nail Psoriasis
Conditions
Keywords
Calcipotriene
Brief 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.
Detailed description
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.
Interventions
DRUGP-3073 (calcipotriene 0.005%)
Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
Once daily for 24 weeks.
Sponsors
Almirall, S.A.
Polichem S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with clear target nail at Week 24 | Week 24 | Defined as Nail Psoriasis Severity Index (NAPSI) =0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with clear target nail matrix at Week 24 | Baseline - Week 24 | Defined as nail matrix in NAPSI=0 |
| Proportion of patients with clear target nail bed at Week 24 | Baseline - Week 24 | Defined as nail bed in NAPSI=0 |
| Proportion of affected nails at baseline with NAPSI=0 at Week 24 | Baseline - Week 24 | Defined as affected nails with NAPSI=0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to reach NAPSI=0 in the target nail | Up to Week 24 | Defined as time until NAPSI=0 |
| Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24 | Baseline - Week 24 | Defined as Nail PGA response rate |
| Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24 | Baseline - Week 24 | Defined as change in VAS |
| Patient Acceptance of Study Therapy at Week 24 | Baseline - Week 24 | Note: Missing values will be replaced with the worst score |
| Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24 | Baseline - Week 24 | Defined as change in EQ-5D-5L |
| Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24 | Baseline - Week 24 | Defined as change in DLQI |
| Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24 | Baseline - Week 24 | Defined as change in SF-36 |
| Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24 | Baseline - Week 24 | Defined as change in NPQ10 |
| Proportion of patients with target nail reaching NAPSI-75% | Baseline - Week 24 | Defined as a reduction of ≥75% from baseline NAPSI score |
| Proportion of affected nails at baseline reaching NAPSI-75% | Baseline - Week 24 | Defined as a reduction of ≥75% from baseline NAPSI score |
| Change from Baseline in Total NAPSI at Week 24 | Baseline - Week 24 | Defined as change in Nail Psoriasis Severity Index |
Countries
United States
Outcome results
None listed