Nail Psoriasis Clinical Trial
Official title:
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
Verified date | March 2018 |
Source | Polichem S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 378 |
Est. completion date | February 8, 2017 |
Est. primary completion date | February 8, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Polichem S.A. |
Bulgaria, Czechia, Germany, Greece, Latvia, Poland, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total Nail Psoriasis Severity Index (NAPSI) | Baseline - Week 24 | ||
Secondary | Change in NAPSI matrix | Baseline - Week 24 | ||
Secondary | Change in NAPSI bed | Week 24 | ||
Secondary | Nail Physician Global Assessment (PGA) response rate | Week 24 | ||
Secondary | Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI) | Baseline - Week 24 | ||
Secondary | Change in discomfort by means of the Visual Analogue Scale (VAS) | Week 24 | ||
Secondary | Proportions of nails with improvement in total NAPSI | Week 24 | ||
Secondary | Proportions of nails with improvement in NAPSI Matrix | Week 24 | ||
Secondary | Proportions of nails with improvement in NAPSI bed | Week 24 | ||
Secondary | 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 |
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