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Completed

NCT Number: NCT04380597

Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and 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.

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Key information

Conditions

Nail Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, 36001, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcipotriene and betamethasone dipropionate aerosol foam

Drug

Prescribed according to clinical practice and following Product Data Sheet instructions

Primary outcomes

  1. Nail Psoriasis Severity Index (NAPSI)

    Time frame: Baseline

    Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis

  2. Nail Psoriasis Severity Index (NAPSI)

    Time frame: Week 12 of treatment

    Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis

  3. Nail Psoriasis Severity Index (NAPSI)

    Time frame: Week 24 of treatment

    Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Angeles Florez

Other

Registry information

Official study title

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

Acronym: ENUPS

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
May 8, 2020
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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