Mild to moderate psoriatic fingernail/s MedDRA version: 18.0 Level: PT Classification code 10028703 Term: Nail psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: P-3073
Product Code: P-3073
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: Calcipotriol Anhydrous
CAS Number: 112965-21-6
Current Sponsor code: P-3073
Other descriptive
Sponsors
Polichem S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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 |
|---|---|
| Main Objective: To evaluate the efficacy of P-3073 in the treatment of nail psoriasis.;Secondary Objective: To evaluate the overall safety and the tolerability of P-3073. ;Primary end point(s): Change from baseline in total NAPSI;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Nail PGA response rate - Change from baseline in NAPSI matrix and NAPSI bed - Change from baseline in patient’s quality-of-life - Change in discomfort - Proportions of nails with improvement in total NAPSI, NAPSI matrix and NAPSI bed - Overall Safety and local tolerability;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Bulgaria, Czech Republic, Germany, Greece, Latvia, Poland, Russian Federation
Contacts
Public ContactDirector, Clinical Development
Polichem S.A.
Outcome results
None listed