Clinical trial NCT05811234: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Mild-to-moderate plaque psoriasis
Prospective
Psoriasis
PRO-SCALP
Plaque psoriasis of the scalp
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Score
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Scalpdex Questionnaire
timeFrame: Baseline up to Week 12
measure: Proportion of Participants Achieving Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12
timeFrame: At Week 4 and 12
measure: Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Ahaus
country: Germany
facility: DE12
city: Augsburg
country: Germany
facility: DE07
city: Frisinga
country: Germany
facility: DE08
city: Köln
country: Germany
facility: DE06
city: Mainz
country: Germany
facility: DE10
city: Mannheim
country: Germany
facility: DE01
city: Mölln
country: Germany
facility: DE05
city: Mönchengladbach
country: Germany
facility: DE03
city: Pforzheim
country: Germany
facility: DE04
city: Potsdam
country: Germany
facility: DE02
city: Remscheid
country: Germany
facility: DE11
city: Alcorcón
country: Spain
facility: ES04
city: Badalona
country: Spain
facility: ES10
city: Barcelona
country: Spain
facility: ES02
city: Barcelona
country: Spain
facility: ES06
city: Barcelona
country: Spain
facility: ES09
city: Bilbao
country: Spain
facility: ES05
city: Granollers
country: Spain
facility: ES03
city: Lleida
country: Spain
facility: ES07
city: Pontevedra
country: Spain
facility: ES08
city: Salamanca
country: Spain
facility: ES12
city: Sevilla
country: Spain
facility: ES11
city: Sevilla
country: Spain
facility: ES13
city: Zaragoza
country: Spain
facility: ES01
city: Blackburn
country: United Kingdom
facility: UK10
city: Chertsey
country: United Kingdom
facility: UK02
city: Chipping Norton
country: United Kingdom
facility: UK06
city: Cockermouth
country: United Kingdom
facility: UK08
city: Crewe
country: United Kingdom
facility: UK03
city: Exeter
country: United Kingdom
facility: UK07
city: Glasgow
country: United Kingdom
facility: UK14
city: Kirkcaldy
country: United Kingdom
facility: UK15
city: Leicester
country: United Kingdom
facility: UK11
city: London
country: United Kingdom
facility: UK01
city: Saint Neots
country: United Kingdom
facility: UK05
city: Salisbury
country: United Kingdom
facility: UK04
city: Wellingborough
country: United Kingdom
facility: UK12
Study officials:
References: