Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Mod… (NCT03079973) | Clinical Trial Compass
WithdrawnPhase 3
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s
Stopped: Project development priorities changed.
United States0Started 2017-05-15
Plain-language summary
The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent before starting any study related procedure.
* Patients ages ≥ 18 and ≤ 80 years old.
* Men or women.
* Outpatients.
* Patients with mild to moderate psoriatic fingernail/s, defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline. The sum of the scores for each nail should range between 1 and 6.
* In case of skin involvement, patients with established clinical diagnosis of mild to moderate psoriasis (BSA involvement ≤ 8% or Psoriasis Area Severity Index (PASI) ≤ 10).
Exclusion Criteria:
* 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 fingernails during the last six months before the screening visit.
* Use of photochemotherapy (phototherapy is allowed) or other forms of radiotherapy during the last four weeks before the screening visit.
* Positive mycology findings (KOH evaluation or culture) obtained in the three months before the screening visit or positive KOH evaluated at the screening visit.
* Patients using nail polish or other nail cosmetic products during last 72 hours prior to study drug application.
* Systemic use of the following therapies for any reason during last three months before the screening visit: immunosuppressives, chemotherapy and corticosteroids (topical use for plaque psoriasis is allowed).
* Consumption of oral Vitamin…
What they're measuring
1
Proportion of patients with clear target nail at Week 24