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

NCT04380597 | Completed FDA Drug

• 1 other identifier: ENUPS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nail Psoriasis

Outcome Measures

Primary Outcomes (3)

• Nail Psoriasis Severity Index (NAPSI)

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

  Baseline

• Nail Psoriasis Severity Index (NAPSI)

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

  Week 12 of treatment

• Nail Psoriasis Severity Index (NAPSI)

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

  Week 24 of treatment

Secondary Outcomes (1)

• Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)

  Baseline, Week 12 of treatment and Week 24 of treatment

Other Outcomes (1)

• Hands Photographs

  Baseline, Week 12 of treatment and Week 24 of treatment

Study Arms (1)

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

Interventions

Calcipotriene and betamethasone dipropionate aerosol foam DRUG

Prescribed according to clinical practice and following Product Data Sheet instructions

Patients with nail psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with any situation or state that in the opinion of the investigator discourages their participation in the study.

Sponsors & Collaborators

• Angeles Florez: lead

Study Sites (1)

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, 36001, Spain

Location

MeSH Terms

Interventions

calcipotriene

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Dermatology

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: May 8, 2020
• Study Start: March 26, 2019
• Primary Completion: December 15, 2019
• Study Completion: July 30, 2021
• Last Updated: August 2, 2021

Record last verified: 2020-05

Locations

ES (1)