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

NCT03616561 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2020-07-29

No results posted yet for this study

Summary

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.

Conditions

  • Nail Psoriasis

Interventions

DRUG

Apremilast

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.

Sponsors & Collaborators

  • Hospital de Sant Joan Despí Moisès Broggi

    collaborator OTHER

  • Hospital de Granollers

    lead OTHER

Principal Investigators

  • Carlos Muñoz, PhD · Hospital General de Granollers

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2020-05-23
Completion
2020-07-23

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616561 on ClinicalTrials.gov