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 (PRO-SCALP)

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)

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: CAL/BDP PAD Cream

• Study Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• Germany
  • Ahaus, Germany
    • DE12
  • Augsburg, Germany
    • DE07
  • Cologne, Germany
    • DE06
  • Freising, Germany
    • DE08
  • Mainz, Germany
    • DE10
  • Mannheim, Germany
    • DE01
  • Mölln, Germany
    • DE05
  • Mönchengladbach, Germany
    • DE03
  • Pforzheim, Germany
    • DE04
  • Potsdam, Germany
    • DE02
  • Remscheid, Germany
    • DE11
• Spain
  • Alcorcón, Spain
    • ES04
  • Badalona, Spain
    • ES10
  • Barcelona, Spain
    • ES02
  • Barcelona, Spain
    • ES06
  • Barcelona, Spain
    • ES09
  • Bilbao, Spain
    • ES05
  • Granollers, Spain
    • ES03
  • Lleida, Spain
    • ES07
  • Pontevedra, Spain
    • ES08
  • Salamanca, Spain
    • ES12
  • Seville, Spain
    • ES11
  • Seville, Spain
    • ES13
  • Zaragoza, Spain
    • ES01
• United Kingdom
  • Blackburn, United Kingdom
    • UK10
  • Chertsey, United Kingdom
    • UK02
  • Chipping Norton, United Kingdom
    • UK06
  • Cockermouth, United Kingdom
    • UK08
  • Crewe, United Kingdom
    • UK03
  • Exeter, United Kingdom
    • UK07
  • Glasgow, United Kingdom
    • UK14
  • Kirkcaldy, United Kingdom
    • UK15
  • Leicester, United Kingdom
    • UK11
  • London, United Kingdom
    • UK01
  • Saint Neots, United Kingdom
    • UK05
  • Salisbury, United Kingdom
    • UK04
  • Wellingborough, United Kingdom
    • UK12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male and female participants with mild-to-moderate plaque psoriasis of the scalp will be observed in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: CAL/BDP PAD Cream; As provided in real-world clinical practice.; Other Names: Wynzora®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at 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.	At end of study observation period (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores	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.	At end of study observation period (Week 12)
Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 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.	At Week 4 and End of study observation period (Week 12)
Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score	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, End of study observation period (Week 12)

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis; Prospective; Mild-to-moderate plaque psoriasis; PRO-SCALP; Plaque psoriasis of the scalp
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: M-22201-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No