A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults

Study Overview
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Brief Summary
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The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.

Official Title
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An International, Prospective, Observational Cohort Study to Assess Patient Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (PRO-SCALP)

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: CAL/BDP PAD Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (greater than or equal to [>=] 18 years) male or female participants with mild-to-moderate plaque psoriasis of the scalp (defined as scalp-PGA score of 2 or 3 at baseline) with or without involvement of the trunk and limbs, and who may or may not have been previously treated (treatment-naive participants) with other anti-psoriatic therapies. Participants who have been prescribed CAL/BDP PAD cream (Wynzora®) treatment to manage plaque psoriasis of the scalp according to SmPC in routine clinical practice. Willingness and ability to participate in the study; participants must give their written consent to participate. Exclusion Criteria: Participants with severe plaque psoriasis, per physician global assessment. Participants with erythrodermic, exfoliative or pustular psoriasis. Participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion. Concomitant systemic treatment with anti-psoriatic drugs. Concomitant treatment of any type for plaque psoriasis of the scalp. Hypersensitivity to the active substances or to any of the excipients of CAL/BDP PAD cream (Wynzora®). Participants with known disorders of calcium metabolism. Participants with viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds. Pregnant or breastfeeding women, except when the potential benefit justifies the potential risk. Participants unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study. Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAL/BDP PAD Cream:<br>Participants who have been prescribed CAL/BDP PAD cream treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 8-12 weeks. | Drug: CAL/BDP PAD Cream<br>* As provided in real-world clinical practice.<br>* Other names: Wynzora®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Score | The TSQM-9 is a psychometrically robust and validated instrument to assess participants satisfaction with the treatment they are receiving. It is a self-administered questionnaire that measures participants drug therapy satisfaction considering the last two or three weeks or since the last time the participant took the medication. It consists of 9 items distributed in 3 domains: effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100. with higher score indicating higher treatment satisfaction. | Baseline up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalpdex Questionnaire | Scalpdex is a scalp dermatitis-specific quality of life (QoL) instrument that can be used to determine which aspect of the disease most bothers the participant and to evaluate QoL as one variable of responsiveness to the therapeutic intervention. It has 23 items, with possible answers scoring on a 5-point Likert-type scale (never = 0, rarely = 25, sometimes = 50, often = 75, and all the time = 100). The final scale scores (symptoms, emotions, and functioning) are calculated by the mean of the item scores pertaining to each scale. A lower score on symptoms, emotions, and functioning represents a better related-QoL for each scale. | Baseline up to Week 12 | 
| Proportion of Participants Achieving Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12 | Scalp-PGA treatment success will be assessed as a scalp-PGA score of zero (0) means no itching and a ten (10) means worst itching imaginable, on the scale of 0-10 end of study observation and with a minimum 2 points improvement from baseline, on the scalp. | At Week 4 and 12 | 
| Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire | WI-NRS is a self-administered scale to assess participants worst level of itching on the scalp (in the last week). The scale has a single-item that describes the worst level of itching on the scalp due to psoriasis in the last week on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable). | Baseline up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild-to-moderate plaque psoriasis, Prospective, Psoriasis, PRO-SCALP, Plaque psoriasis of the scalp