Study to evaluate the efficacy and safety of P-3073 solution in the treatment of nails affected by psoriasis.

Phase 1

Conditions: Mild to moderate psoriatic fingernail/s
MedDRA version: 19.0Level: PTClassification code 10028703Term: Nail psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-002365-34-DE

Lead Sponsor: Polichem S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

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

- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- 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 fingernail 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 oral Vitamin D or its analogues during the last three months (calcipotriol topical use for plaque psoriasis is allowed).
- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Nail PGA response rate<br>- Change from baseline in NAPSI matrix and NAPSI bed<br>- Change from baseline in patient’s quality-of-life<br>- Change in discomfort<br>- Proportions of nails with improvement in total NAPSI, NAPSI matrix and NAPSI bed<br>- Patient acceptance of study therapy<br>- Overall Safety and local tolerability;Timepoint(s) of evaluation of this end point: Week 24