N/A
N=291
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
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05811234 ↗Enrolled (actual)
291
Serious AEs
0.7%
Results posted
Sep 2025
Primary outcome: Primary: Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12 — 73.56; 72.07; 75.97 Score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CAL/BDP PAD Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Almirall, S.A.
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12 |
73.56; 72.07; 75.97 | — |
| SECONDARY Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores |
22.66; 29.53; 26.88 | — |
| SECONDARY Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12 |
48.00; 52.00; 68.40; 31.60 | — |
| SECONDARY Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score |
6.43; 2.66 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05811234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.