Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)

Conditions

• Nail Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Target nail ultrasound will be performed in patients on apremilast by two expert dermatologists and each one will determine the ecographic parameters described in the protocol. These variables would be measured in one target nail in each patient, the greatest and most severely affected, at the investigator's criterion. The same nail will be assessed in all visits of the study (baseline, weeks 4, 16, 24, 38 and 52) . The ultrasound study will be performed with the same device in both hospitals: Esaote's MyLab ultrasound with a 20 MHz transducer. Prior to the start of the study the investigators evaluated the ultrasonographic inter-intraobserver concordance.

Study Details

Prospective open label non-randomized study, using Apremilast according to the manufacturer's Summary of Product Characteristics for 52 weeks, in patients with moderate to severe plaque psoriasis and nail psoriasis The study will be carried out in two hospital centers with experience in the management of patients with psoriasis and in the use of ultrasound of the nail apparatus. Visits and ultrasound would be performed by prescribing doctors themselves in their outpatient offices. Prior to the start of the study, the two doctors of each center will conduct a study to see the intraobserver and interobserver agreement on the ecographic parameters. The medication would be dispensed and controlled in the centers themselves and self-administered by patients at home. Each visit includes a ultrasound assessment of a target nail and measures of different scales: NAPSI, NAPPA.

Key Dates

First listed

Aug 6, 2018

Start date

Feb 23, 2018

Status verified

Jul 2020

Primary completion

May 23, 2020

Completion

Jul 23, 2020

Study Design

Enrollment

45 participants (actual)

Arms

• Arm: Apremilast
  The cohort will be recruited in Hospital General de Granollers and Hospital Moises Broggi

Primary Outcome Measure

Questionnaire: NAPPA- PBI changes [ Time Frame: first visit and week 4, 16, 24, 38 and 52 ]