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

NCT05811234 | Completed Results

• 1 other identifier: M-22201-41
• Study Type: observational
• Target: 291
• Locations: 3 countries
• Sites: 37

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.

Conditions

Plaque Psoriasis

Keywords

Mild-to-moderate plaque psoriasis; Prospective; Psoriasis; PRO-SCALP; Plaque psoriasis of the scalp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores

  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

  At Week 4 and End of study observation period (Week 12)

• Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score

  Baseline, End of study observation period (Week 12)

Study Arms (1)

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

Interventions

CAL/BDP PAD Cream DRUG

As provided in real-world clinical practice.

Also known as: Wynzora®

CAL/BDP PAD Cream:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participants with severe plaque psoriasis, per physician global assessment.
• Participants with erythrodermic, exfoliative or pustular psoriasis.
• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (37)

DE12

Ahaus, Germany

Location

DE07

Augsburg, Germany

Location

DE06

Cologne, Germany

Location

DE08

Freising, Germany

Location

DE10

Mainz, Germany

Location

DE01

Mannheim, Germany

Location

DE05

Mölln, Germany

Location

DE03

Mönchengladbach, Germany

Location

DE04

Pforzheim, Germany

Location

DE02

Potsdam, Germany

Location

DE11

Remscheid, Germany

Location

ES04

Alcorcón, Spain

Location

ES10

Badalona, Spain

Location

ES02

Barcelona, Spain

Location

ES06

Barcelona, Spain

Location

ES09

Barcelona, Spain

Location

ES05

Bilbao, Spain

Location

ES03

Granollers, Spain

Location

ES07

Lleida, Spain

Location

ES08

Pontevedra, Spain

Location

ES12

Salamanca, Spain

Location

ES11

Seville, Spain

Location

ES13

Seville, Spain

Location

ES01

Zaragoza, Spain

Location

UK10

Blackburn, United Kingdom

Location

UK02

Chertsey, United Kingdom

Location

UK06

Chipping Norton, United Kingdom

Location

UK08

Cockermouth, United Kingdom

Location

UK03

Crewe, United Kingdom

Location

UK07

Exeter, United Kingdom

Location

UK14

Glasgow, United Kingdom

Location

UK15

Kirkcaldy, United Kingdom

Location

UK11

Leicester, United Kingdom

Location

UK01

London, United Kingdom

Location

UK05

Saint Neots, United Kingdom

Location

UK04

Salisbury, United Kingdom

Location

UK12

Wellingborough, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head of Global Clinical Development
• Organization: Almirall S.A

gco@almirall.com

+34932913000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: June 13, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); ES (13); GB (13)