Nail Psoriasis Clinical Trial
— ENUPSOfficial 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
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 |
Verified date | May 2020 |
Source | Complejo Hospitalario Universitario de Pontevedra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario de Pontevedra | Pontevedra |
Lead Sponsor | Collaborator |
---|---|
Angeles Florez |
Spain,
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 |
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