Trial Outcomes & Findings for 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 (NCT NCT05811234)
NCT ID: NCT05811234
Last Updated: 2025-09-24
Results Overview
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.
COMPLETED
291 participants
At end of study observation period (Week 12)
2025-09-24
Participant Flow
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.
A total of 291 participants were enrolled in this study.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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291
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Overall Study
Safety Population
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291
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Overall Study
Full Analysis Set (FAS)
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253
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Overall Study
COMPLETED
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265
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Overall Study
NOT COMPLETED
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26
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Loss of Effectiveness
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2
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Overall Study
Adverse Event
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4
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Overall Study
Pregnancy
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1
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Overall Study
Disease progression
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1
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Overall Study
Withdrawal by Subject
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4
|
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Overall Study
Lost to Follow-up
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13
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Overall Study
Personal reason, or the patient stops taking the study treatment
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1
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Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
CAL/BDP PAD Cream
n=291 Participants
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.
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|---|---|
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Age, Continuous
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47.88 years
STANDARD_DEVIATION 17.40 • n=291 Participants
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Sex: Female, Male
Female
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187 Participants
n=291 Participants
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Sex: Female, Male
Male
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104 Participants
n=291 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=291 Participants
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Race (NIH/OMB)
Asian
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11 Participants
n=291 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=291 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=291 Participants
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Race (NIH/OMB)
White
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265 Participants
n=291 Participants
|
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Race (NIH/OMB)
More than one race
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8 Participants
n=291 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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5 Participants
n=291 Participants
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PRIMARY outcome
Timeframe: At end of study observation period (Week 12)Population: FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.
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.
Outcome measures
| Measure |
CAL/BDP PAD Cream
n=253 Participants
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.
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|---|---|
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Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12
Effectiveness Total Score: At Week 12
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73.56 Score on a scale
Interval 70.41 to 76.71
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Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12
Convenience Total Score: At Week 12
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72.07 Score on a scale
Interval 69.65 to 74.49
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Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12
Global Satisfaction Total Score: At Week 12
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75.97 Score on a scale
Interval 73.3 to 78.65
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SECONDARY outcome
Timeframe: At end of study observation period (Week 12)Population: FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.
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.
Outcome measures
| Measure |
CAL/BDP PAD Cream
n=253 Participants
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.
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|---|---|
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Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores
Symptoms: At Week 12
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22.66 Score on a scale
Interval 20.37 to 24.95
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Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores
Emotions: At Week 12
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29.53 Score on a scale
Interval 27.08 to 31.99
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Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores
Functioning: At Week 12
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26.88 Score on a scale
Interval 24.22 to 29.53
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SECONDARY outcome
Timeframe: At Week 4 and End of study observation period (Week 12)Population: 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.
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.
Outcome measures
| Measure |
CAL/BDP PAD Cream
n=250 Participants
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.
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|---|---|
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Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12
Scalp-PGA Success at Week 4: Yes
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48.00 Percentage of participants
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Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12
Scalp-PGA Success at Week 4: No
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52.00 Percentage of participants
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Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12
Scalp-PGA Success at Week 12: Yes
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68.40 Percentage of participants
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Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12
Scalp-PGA Success at Week 12: No
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31.60 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline, End of study observation period (Week 12)Population: FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.
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).
Outcome measures
| Measure |
CAL/BDP PAD Cream
n=253 Participants
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.
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|---|---|
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Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score
Baseline
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6.43 Score on a scale
Interval 6.13 to 6.73
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Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score
At Week 12
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2.66 Score on a scale
Interval 2.34 to 2.97
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Adverse Events
CAL/BDP PAD Cream
Serious adverse events
| Measure |
CAL/BDP PAD Cream
n=291 participants at risk
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.
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
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Infections and infestations
Pneumonia
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
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Other adverse events
| Measure |
CAL/BDP PAD Cream
n=291 participants at risk
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.
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|---|---|
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Eye disorders
Conjunctivitis
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
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Gastrointestinal disorders
Dyspepsia
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
|
Infections and infestations
Influenza
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
|
Infections and infestations
Localised Infection
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
|
Infections and infestations
Nasopharyngitis
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
|
Infections and infestations
Oral Herpes
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
|
Infections and infestations
Pneumonia
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
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Musculoskeletal and connective tissue disorders
Polyarthritis
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
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Skin and subcutaneous tissue disorders
Folliculitis
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0.69%
2/291 • Baseline up to end of study observation period (Week 12)
|
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Skin and subcutaneous tissue disorders
Urticaria Chronic
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
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Vascular disorders
Hypertension
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
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0.34%
1/291 • Baseline up to end of study observation period (Week 12)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER