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Plaque PsoriasisPRO-SCALPNCT05811234

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

An observational study of Plaque Psoriasis, run by Almirall, S.A. at 37 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
CAL/BDP PAD Cream
How many people
291 participants
Where
37 sitesin 3 countries
Study dates
13 Jun 2023to 1 Oct 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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®).
Show all 11Show fewer
  • 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.

Trial locations and contacts

37 sites in 3 countries.

37 sites in 3 countries

Spain13 sites

  • ES04

    Alcorcón

  • ES10

    Badalona

  • ES02

    Barcelona

  • ES06

    Barcelona

  • ES09

    Barcelona

  • ES05

    Bilbao

  • ES03

    Granollers

  • ES07

    Lleida

  • ES08

    Pontevedra

  • ES12

    Salamanca

  • ES11

    Seville

  • ES13

    Seville

  • ES01

    Zaragoza

Other trials in Spain

United Kingdom13 sites

  • UK10

    Blackburn

  • UK02

    Chertsey

  • UK06

    Chipping Norton

  • UK08

    Cockermouth

  • UK03

    Crewe

  • UK07

    Exeter

  • UK14

    Glasgow

  • UK15

    Kirkcaldy

  • UK11

    Leicester

  • UK01

    London

  • UK05

    Saint Neots

  • UK04

    Salisbury

  • UK12

    Wellingborough

Other trials in United Kingdom

Germany11 sites

  • DE12

    Ahaus

  • DE07

    Augsburg

  • DE06

    Cologne

  • DE08

    Freising

  • DE10

    Mainz

  • DE01

    Mannheim

  • DE05

    Mölln

  • DE03

    Mönchengladbach

  • DE04

    Pforzheim

  • DE02

    Potsdam

  • DE11

    Remscheid

Other trials in Germany

About this study

Official title: 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.

Being tested
CAL/BDP PAD Cream
Keywords
Mild-to-moderate plaque psoriasis, Prospective, Psoriasis, PRO-SCALP, Plaque psoriasis of the scalp
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAL/BDP PAD CreamDrug

    Also called Wynzora®

    As provided in real-world clinical practice.

Study groups in NCT05811234
Study groupRoleWhat they receive
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.
Receives: Drug: CAL/BDP PAD Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At end of study observation period (Week 12)

Secondary outcomes (3)

  1. 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.

    Measured: At end of study observation period (Week 12)

  2. 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.

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

  3. 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).

    Measured: Baseline, End of study observation period (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start13 Jun 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811234
Sponsor's protocol ID
M-22201-41
Acronym
PRO-SCALP
Status last verified
Sep 2025
First submitted
31 Mar 2023
Last updated
24 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bewley A, Pinter A, Lopez Estebaranz JL, Galvan J, Sapena V, Koscielny V. Adherence to CAL/BDP PAD-Cream Influences Treatment Effectiveness and Preference in Scalp Psoriasis Under Real-Life Conditions: Results from the Prospective, Multicenter, Observational PRO-SCALP Study. Dermatol Ther (Heidelb). 2026 Aug 10. doi: 10.1007/s13555-026-01884-x. Online ahead of print.

    PubMed 42573965

  • Lopez Estebaranz JL, Bewley A, Pinter A, Galvan J, Koscielny V. Patient- and clinician-reported outcomes of calcipotriol/betamethasone dipropionate PAD-cream for the treatment of adult patients with scalp psoriasis under real-world conditions: results from the prospective, noninterventional, multicentre PRO-SCALP study. Clin Exp Dermatol. 2026 Sep 25;51(10):1855-1864. doi: 10.1093/ced/llag185.

    PubMed 42052895

Questions about this trial

What is this clinical trial studying?

An observational study of Plaque Psoriasis, run by Almirall, S.A. at 37 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Spain, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12 (time frame: At end of study observation period (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05811234, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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