Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life (ENUPS)

July 30, 2021 updated by: Angeles Florez

Observational and Prospective Study in Patients With Nail Psoriasis Treated With Calcipotriene and Betamethasone Dipropionate Aerosol Foam to Evaluate the Change in the Severity of Psoriasis and in the Quality of Life

Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), prescribed according to clinical practice and following the Product Data Sheet instructions, in the topical treatment of nail psoriasis according to the change in the score of the Nail Psoriasis Severity Index (NAPSI) at 12 weeks of treatment with respect to the initial score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Pontevedra, Spain, 36001
        • Complejo Hospitalario Universitario de Pontevedra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed of nail psoriasis for whom are prescribed, according to clinical practice, a topical treatment. Will be included the first 60 patients that consecutively attend the participating centers and meet all the eligibility criteria.

Description

Inclusion Criteria:

  • Patients with nail psoriasis who start, according to clinical practice, topical treatment with calcipotriene and betamethasone dipropionate aerosol foam
  • Patients who authorize their participation in the study by signing written informed consent.

Exclusion Criteria:

  • Patients receiving treatment with systemic drugs or their prescription is scheduled for the next 3 months. However, may be included patients who receive the same systemic treatment regimen from at least 6 months before their inclusion in the study and up to 14 weeks later.
  • Patients with any situation or state that in the opinion of the investigator discourages their participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with nail psoriasis
Patients with nail psoriasis who are prescribed, according to clinical practice, a topical treatment with calcipotriene and betamethasone dipropionate aerosol foam.
Drug: Calcipotriene and betamethasone dipropionate aerosol foam
Prescribed according to clinical practice and following Product Data Sheet instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nail Psoriasis Severity Index (NAPSI)
Time Frame: Baseline
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Baseline
Nail Psoriasis Severity Index (NAPSI)
Time Frame: Week 12 of treatment
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Week 12 of treatment
Nail Psoriasis Severity Index (NAPSI)
Time Frame: Week 24 of treatment
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Week 24 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)
Time Frame: Baseline, Week 12 of treatment and Week 24 of treatment
Modular instrument for the assessment of clinical and patient-reported outcomes in nails.
Baseline, Week 12 of treatment and Week 24 of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hands Photographs
Time Frame: Baseline, Week 12 of treatment and Week 24 of treatment
High-quality photographs on patient´s both hands to document the psoriasis status
Baseline, Week 12 of treatment and Week 24 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angeles Florez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2019

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENUPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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