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
- Conditions
- Plaque Psoriasis
- Interventions
- Drug: CAL/BDP PAD Cream
- Registration Number
- NCT05811234
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 291
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CAL/BDP PAD Cream: CAL/BDP PAD Cream 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.
- Primary Outcome Measures
Name Time Method Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Score Baseline up to Week 12 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.
- Secondary Outcome Measures
Name Time Method Scalpdex Questionnaire Baseline up to Week 12 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.
Proportion of Participants Achieving Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12 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.
Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Baseline up to Week 12 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).
Trial Locations
- Locations (37)
UK03
🇬🇧Crewe, United Kingdom
UK06
🇬🇧Chipping Norton, United Kingdom
UK08
🇬🇧Cockermouth, United Kingdom
UK15
🇬🇧Kirkcaldy, United Kingdom
UK11
🇬🇧Leicester, United Kingdom
UK04
🇬🇧Salisbury, United Kingdom
UK12
🇬🇧Wellingborough, United Kingdom
DE07
🇩🇪Augsburg, Germany
DE12
🇩🇪Ahaus, Germany
ES10
🇪🇸Badalona, Spain
UK14
🇬🇧Glasgow, United Kingdom
DE01
🇩🇪Mannheim, Germany
DE10
🇩🇪Mainz, Germany
ES04
🇪🇸Alcorcón, Spain
DE11
🇩🇪Remscheid, Germany
DE08
🇩🇪Frisinga, Germany
DE05
🇩🇪Mölln, Germany
ES02
🇪🇸Barcelona, Spain
DE04
🇩🇪Pforzheim, Germany
DE06
🇩🇪Köln, Germany
ES09
🇪🇸Barcelona, Spain
ES11
🇪🇸Sevilla, Spain
UK10
🇬🇧Blackburn, United Kingdom
UK02
🇬🇧Chertsey, United Kingdom
ES06
🇪🇸Barcelona, Spain
ES03
🇪🇸Granollers, Spain
ES05
🇪🇸Bilbao, Spain
ES12
🇪🇸Salamanca, Spain
ES13
🇪🇸Sevilla, Spain
ES01
🇪🇸Zaragoza, Spain
DE03
🇩🇪Mönchengladbach, Germany
DE02
🇩🇪Potsdam, Germany
ES08
🇪🇸Pontevedra, Spain
ES07
🇪🇸Lleida, Spain
UK01
🇬🇧London, United Kingdom
UK07
🇬🇧Exeter, United Kingdom
UK05
🇬🇧Saint Neots, United Kingdom