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 Clinical Trial

— PRO-SCALP  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811234
• Other study ID #: M-22201-41
• Status: Recruiting
• Start date: June 13, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: Almirall, S.A.
• Contact: Jordi Galvan
• Phone: +34932913000
• Email: jordi.galvan[@]almirall.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• CAL/BDP PAD Cream
As provided in real-world clinical practice.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Score	The TSQM-9 is a psychometrically robust and validated instrument to assess participants satisfaction with the treatment they are receiving. It is a self-administered questionnaire that measures participants drug therapy satisfaction considering the last two or three weeks or since the last time the participant took the medication. It consists of 9 items distributed in 3 domains: effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100. with higher score indicating higher treatment satisfaction.	Baseline up to Week 12
Secondary	Scalpdex Questionnaire	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 ("never" = 0, "rarely" = 25, "sometimes" = 50, "often" = 75, and "all the time" = 100). The final scale scores (symptoms, emotions, and functioning) are calculated by the mean of the item scores pertaining to each scale. A lower score on symptoms, emotions, and functioning represents a better related-QoL for each scale.	Baseline up to Week 12
Secondary	Proportion of Participants Achieving Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12	Scalp-PGA treatment success will be assessed as a scalp-PGA score of zero (0) means "no itching" and a ten (10) means "worst itching imaginable", on the scale of 0-10 end of study observation and with a minimum 2 points improvement from baseline, on the scalp.	At Week 4 and 12
Secondary	Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire	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 up to Week 12