E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nail psoriasis of the nail matrix and / or the nail bed at fingernails (at least one should be affected) |
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E.1.1.1 | Medical condition in easily understood language |
Fingernails with clinical signs of psoriasis. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This is a pilot study, all objectives are exploratory:
• 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 each study visit
•To evaluate the changes of nail thickness of the affected nails by means of 20 MHz ultrasound at each study visit
• Evaluation of the safety profile of P-3072 and P-3073 at each study visit by means of AE monitoring
• To evaluate the changes in patient’s quality of life at each study visit
•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
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 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 γGT 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Thia is a pilot study all end-points are exploratory:
• 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 all affected nails evaluated by means of NAPSI score
• Reduction of nail thickness of all affected nails evaluated by means of 20 MHz ultrasound
• Evaluation of the safety profile of P-3072 and P-3073 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
• 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 (Visual Analogue Scale)
• Patient’s opinion on the product effectiveness and on its acceptability evaluated by means of patient’s diary
• Blood and nail concentrations of Cyclosporine and Calcipotriol |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At each study visit, at the end of treatmentand and at the follow-up visit |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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It is last patient last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |