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

Completed

• 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

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-13
• Study Start: 2023-06-13
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2025-09
• Results First Submitted: 2025-09-04
• Results First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Results First Posted: 2025-09-24
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

1. 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.
2. 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.
3. Willingness and ability to participate in the study; participants must give their written consent to participate.

Exclusion Criteria

1. Participants with severe plaque psoriasis, per physician global assessment.
2. Participants with erythrodermic, exfoliative or pustular psoriasis.
3. Participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion.
4. Concomitant systemic treatment with anti-psoriatic drugs.
5. Concomitant treatment of any type for plaque psoriasis of the scalp.
6. Hypersensitivity to the active substances or to any of the excipients of CAL/BDP PAD cream (Wynzora®).
7. Participants with known disorders of calcium metabolism.
8. 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.
9. Pregnant or breastfeeding women, except when the potential benefit justifies the potential risk.
10. 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.
11. 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
Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12	At end of study observation period (Week 12)	TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.

Secondary Outcome Measures

Name	Time	Method
Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores	At end of study observation period (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 of 0 to 100 ("never" = 0, "rarely" = 25, "sometimes" = 50, "often" = 75, and "all the time" = 100). The final domine scores (symptoms, emotions, and functioning) are calculated by the mean of the item scores pertaining to each scale is the average of the scores of the 23 items with range of 0 to 100. A lower score on symptoms, emotions, and functioning represents a better related-QoL for each scale.
Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12	At Week 4 and End of study observation period (Week 12)	Scalp-PGA treatment success was defined as a scalp-PGA score of 0 (clear) or 1 (almost clear) and with a minimum 2 points improvement from baseline, on the scalp.
Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score	Baseline, End of study observation period (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)

DE12; 🇩🇪 Ahaus, Germany

DE07; 🇩🇪 Augsburg, Germany

DE06; 🇩🇪 Cologne, Germany

DE08; 🇩🇪 Freising, Germany

DE10; 🇩🇪 Mainz, Germany

DE01; 🇩🇪 Mannheim, Germany

DE05; 🇩🇪 Mölln, Germany

DE03; 🇩🇪 Mönchengladbach, Germany

DE04; 🇩🇪 Pforzheim, Germany

DE02; 🇩🇪 Potsdam, Germany

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