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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAL/BDP PAD Cream | Drug | As provided in real-world clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At end of study observation period (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult male and female participants with mild-to-moderate plaque psoriasis of the scalp will be observed in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DE12 | Ahaus | Germany | ||||
| DE07 |
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A total of 291 participants were enrolled in this study.
This study was conducted at 33 sites across three European countries (Germany, Spain, and the United Kingdom) from 13 June 2023 to 01 October 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAL/BDP PAD Cream | Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2023 | Aug 1, 2025 |
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| At end of study observation period (Week 12) |
| 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. | At Week 4 and End of study observation period (Week 12) |
| 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). | Baseline, End of study observation period (Week 12) |
| Augsburg |
| Germany |
| DE06 | Cologne | Germany |
| DE08 | Freising | Germany |
| DE10 | Mainz | Germany |
| DE01 | Mannheim | Germany |
| DE05 | Mölln | Germany |
| DE03 | Mönchengladbach | Germany |
| DE04 | Pforzheim | Germany |
| DE02 | Potsdam | Germany |
| DE11 | Remscheid | Germany |
| 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 | Seville | Spain |
| ES13 | Seville | Spain |
| ES01 | Zaragoza | Spain |
| 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 | United Kingdom |
| Safety Population | Safety population included all participants for whom it is known that they had at least one CAL/BDP PAD cream application during the study observation period. |
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| Full Analysis Set (FAS) | FAS included all those participants in the safety population that had at least one post-baseline assessment* for primary endpoint. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants for whom it is known that they had at least one CAL/BDP PAD cream application during the study observation period.
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| ID | Title | Description |
|---|---|---|
| BG000 | CAL/BDP PAD Cream | Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint. | Posted | Mean | 95% Confidence Interval | Score on a scale | At end of study observation period (Week 12) |
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| Secondary | 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. | FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint. | Posted | Mean | 95% Confidence Interval | Score on a scale | At end of study observation period (Week 12) |
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| Secondary | 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. | FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies who were evaluable at specific timepoints. | Posted | Number | Percentage of participants | At Week 4 and End of study observation period (Week 12) |
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| Secondary | 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). | FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint. | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline, End of study observation period (Week 12) |
|
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Baseline up to end of study observation period (Week 12)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAL/BDP PAD Cream | Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks. | 1 | 291 | 2 | 291 | 13 | 291 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Localised Infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Urticaria Chronic | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Global Clinical Development | Almirall S.A | +34932913000 | gco@almirall.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2024 | Aug 1, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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