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

Completed

• Conditions: Nail Psoriasis
• Interventions: Drug: Calcipotriene and betamethasone dipropionate aerosol foam

• Registration Number: NCT04380597
• Lead Sponsor: Angeles Florez

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-07
• Study Start: 2019-03-26
• Primary Completion: 2019-12-15
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Study Completion: 2021-07-30
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with nail psoriasis	Calcipotriene and betamethasone dipropionate aerosol foam	Patients with nail psoriasis who are prescribed, according to clinical practice, a topical treatment with calcipotriene and betamethasone dipropionate aerosol foam.

Primary Outcome Measures

Name	Time	Method
Nail Psoriasis Severity Index (NAPSI)	Week 24 of treatment	Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Complejo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain