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

Nail Psoriasis Clinical Trial

— ENUPS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380597
• Other study ID #: ENUPS
• Status: Completed
• Start date: March 26, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: May 2020
• Source: Complejo Hospitalario Universitario de Pontevedra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 30, 2021
• Est. primary completion date: December 15, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

Drug:
• Calcipotriene and betamethasone dipropionate aerosol foam
Prescribed according to clinical practice and following Product Data Sheet instructions

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Pontevedra	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Angeles Florez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hands Photographs	High-quality photographs on patient´s both hands to document the psoriasis status	Baseline, Week 12 of treatment and Week 24 of treatment
Primary	Nail Psoriasis Severity Index (NAPSI)	Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis	Baseline
Primary	Nail Psoriasis Severity Index (NAPSI)	Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis	Week 12 of treatment
Primary	Nail Psoriasis Severity Index (NAPSI)	Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis	Week 24 of treatment
Secondary	Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)	Modular instrument for the assessment of clinical and patient-reported outcomes in nails.	Baseline, Week 12 of treatment and Week 24 of treatment