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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nail Psoriasis

Intervention / Treatment
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* Drug: Calcipotriene and betamethasone dipropionate aerosol foam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with nail psoriasis<br>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<br>* Prescribed according to clinical practice and following Product Data Sheet instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |