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Completed

NCT Number: 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

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.

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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DE12, Ahaus, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAL/BDP PAD Cream

Drug

As provided in real-world clinical practice.

Other names: Wynzora®

Primary outcomes

  1. 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)

    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.

Secondary outcomes

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

    Time frame: At end of study observation period (Week 12)

    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.

  2. Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12

    Time frame: At Week 4 and End of study observation period (Week 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.

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

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

    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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study 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)

Acronym: PRO-SCALP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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