EUCTR2015-002365-34-GRActive, not recruitingPhase 1
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
Polichem S.A.0 sites330 target enrollmentStarted: December 7, 2015Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 330
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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.
Investigators
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