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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04380597
Other study ID # ENUPS
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
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