Nail Psoriasis
Conditions
Keywords
Nail psoriasis
Brief summary
The purpose of this study is to confirm the clinical efficacy and the 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.
Interventions
DRUGP-3073
Sponsors
Polichem S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent before starting any study related procedures * Patients aged 18 to 80 years old of any race. * Males or females. * Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline. * In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement ≤ 8% or PASI ≤ 10)
Exclusion criteria
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period. * Use of any systemic treatment for psoriasis during the last six months before the screening visit. * Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit. * Positive mycology findings * Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit. * Consumption of Vitamin D or its analogues during the last three months. * History of hypercalcaemia or hypercalciuria. * HIV infection or any other immunodeficiency. * Alcohol or substance abuse. * Patients with history of allergic reactions to calcipotriol or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total Nail Psoriasis Severity Index (NAPSI) | Baseline - Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in NAPSI bed | Week 24 |
| Nail Physician Global Assessment (PGA) response rate | Week 24 |
| Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI) | Baseline - Week 24 |
| Change in discomfort by means of the Visual Analogue Scale (VAS) | Week 24 |
| Change in NAPSI matrix | Baseline - Week 24 |
| Proportions of nails with improvement in NAPSI Matrix | Week 24 |
| Proportions of nails with improvement in NAPSI bed | Week 24 |
| Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. | Week 24 |
| Proportions of nails with improvement in total NAPSI | Week 24 |
Countries
Bulgaria, Czechia, Germany, Greece, Latvia, Poland, Russia
Outcome results
None listed