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To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.
An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Active Comparator | Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel |
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| Treatment group 2 | Active Comparator | Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 Aerosol Foam | Drug | Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'. The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website. | 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, the assigned score were from -2=very dissatisfied to 2=very satisfied. Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains' items. A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain. |
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Papp, MD phD | K. Papp Clinical Research INC. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K.Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1CR | Canada |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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Screening assessments were performed at the Screening Visit which could occur up to 28 days prior to Baseline (Day 1; Visit 1). A washout period of up to 4 weeks was to be completed if the subject was treated or had recently been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria.
219 subjects from Canada (8 sites) and Germany (7 sites) were enrolled into the trial. First Subject First Visit:10-Feb-2015 and Last Subject Last Visit: 03-Aug-2015 (last visit, including follow-up). 6 enrolled subjects were not randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Foam - Gel | Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week. |
| FG001 | Gel - Foam | Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Day 1 - Day 7) |
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| Second Intervention (Day 8 - Day 14) |
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One subject in the foam-gel group discontinued from the trial prior to the Week 1 visit and did not complete any on-treatment questionnaires. This subject was excluded from the full analysis set which hence comprised 212 subjects: 108 subjects in the foam-gel group and 104 subjects in the gel-foam group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Foam - Gel | Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel |
| BG001 | Gel - Foam | Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam |
| 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, Categorical | Count of Participants |
| 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 | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'. The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website. | Posted | Number | percentage of subjects | 2 weeks |
|
2 weeks
21 subjects (9.9%) experienced a total of 21 treatment-emergent AEs. No SAEs, severe AEs or AEs leading to withdrawal were observed. 2 subjects had AEs which were assessed as related to study treatment by the investigator: one subject in the foam-gel group experienced folliculitis, and one subject in the gel-foam group experienced dermatitis.
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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 | Foam - Gel | Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 44945888 | ctr.disclosure@leo-pharma.com |
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| Daivobet® gel | Drug | Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week. |
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| 2 weeks |
| Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | The TPUQ tool was used to evaluate the subject's latest topical treatment at Baseline (used within 3 months prior to baseline). TPUQ assessments of trial treatments at Week 1 and Week 2. Each response category (item 1 to 25) was assigned a numeric score from-2=strongly disagree to 2=strongly agree. For item 26 the assigned scores were from -2=very dissatisfied to 2=very satisfied. Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score. The higher score signifies higher preference in that domain. | Baseline to Week 2 |
| Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel) | Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference. The subjects compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either 'prefer latest treatment', 'no preference', or 'prefer trial medication (foam or gel)'. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel. | At Week 1 and Week 2 |
| Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21. | At Week 1 and Week 2 |
| Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel) | Baseline to Week 2 |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG000 | All Randomised Subjects | All randomised subjects (foam - gel and gel - foam) |
| OG001 | Foam - Gel | Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel |
| OG002 | Gel - Foam | Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam |
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| Other Pre-specified | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, the assigned score were from -2=very dissatisfied to 2=very satisfied. Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains' items. A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Other Pre-specified | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | The TPUQ tool was used to evaluate the subject's latest topical treatment at Baseline (used within 3 months prior to baseline). TPUQ assessments of trial treatments at Week 1 and Week 2. Each response category (item 1 to 25) was assigned a numeric score from-2=strongly disagree to 2=strongly agree. For item 26 the assigned scores were from -2=very dissatisfied to 2=very satisfied. Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score. The higher score signifies higher preference in that domain. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 2 |
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| Other Pre-specified | Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel) | Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference. The subjects compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either 'prefer latest treatment', 'no preference', or 'prefer trial medication (foam or gel)'. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel. | CLTT analysis set was defined by including all randomised subjects who had used topical anti-psoriatic medication on the treatment area (trunk and/or limbs) within 3 months prior to Baseline. | Posted | Number | percentage of subjects | At Week 1 and Week 2 |
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| Other Pre-specified | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21. | Posted | Mean | Standard Deviation | units on a scale | At Week 1 and Week 2 |
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| Other Pre-specified | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel) | In total 103 preferred foam and 105 preferred gel. 4 subjects ... | Posted | Number | percentage of subjects | Baseline to Week 2 |
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| 0 |
| 109 |
| 13 |
| 109 |
| EG001 | Gel - Foam | Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week. | 0 | 104 | 8 | 104 |
| Bronchitis | Infections and infestations | MedDRA (15.1) |
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| Folliculitis | Infections and infestations | MedDRA (15.1) |
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| Gastrointestinal infection | Infections and infestations | MedDRA (15.1) |
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| Oral herpes | Infections and infestations | MedDRA (15.1) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) |
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| Nausea | Gastrointestinal disorders | MedDRA (15.1) |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (15.1) |
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| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (15.1) |
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| Application site pruritus | General disorders | MedDRA (15.1) | General disorders and administration site conditions |
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| Arthroscopy | Investigations | MedDRA (15.1) |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) |
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| Headache | Nervous system disorders | MedDRA (15.1) |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
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| Hypertension | Vascular disorders | MedDRA (15.1) |
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LEO acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| 3. Ease of spreading |
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| 4. Lack of mess when applying |
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| 5. Good for use on smaller areas |
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| 6. Good for use on larger areas |
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| 7. Quick to apply |
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| 8. Total time spent acceptable |
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| 9. Easily incorporated into daily routine |
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| Total application score (summary score item 1-9) |
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| 10. Quickly absorbed |
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| 11. Dried quickly |
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| 12. Gave an immediate feeling of relief |
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| 13. Felt soothing to my skin |
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| 14. Appealing to touch |
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| 15. Felt moisturising to my skin |
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| 16. Not greasy |
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| 17. Odourless |
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| 18. Lack of staining of clothes/bed linen |
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| Total formulation score (summary score item 10-18) |
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| 19. Easy to get medication out of container |
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| 20. Easy to use container |
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| 21. Easy to keep container clean |
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| 22. Accurately dispense wanted amount |
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| Total container score (summary score item 19-22) |
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| 23. Confidence in using the product |
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| 24. Would regularly use the product |
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| 25. Would recommend the product |
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| Total satisfaction score(summary score item 23-25) |
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| Total TPUQ score (summary score item 1-25) |
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| 26. Overall satisfaction score |
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| Total container score (sum score items 19-22) |
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| Total satisfaction score (sum score items 23-25) |
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| Total TPUQ score (items 1-25) |
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| 26. Overall satisfaction score |
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Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment. |
| Wilcoxon Signed Rank Test |
Wilcoxon signed rank test comparing within subject difference to latest topical treatment |
| <0.001 |
| Superiority or Other (legacy) |
| How well it is absorbed |
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| How it feels to touch |
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| How it smells |
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| How it feels on the skin |
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| How much it stains |
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| Total VPM score (summary score) |
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| Easy application on psoriasis lesions only |
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| Easy to spread |
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| Applying the medication was not messy |
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| Overall good for smaller areas |
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| Overall good for larger areas |
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| Treatment was quick to apply |
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| Total time spent on treatment acceptable |
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| Applying treatment easy in daily routine |
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| Treatment quickly absorbed |
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| Treatment dried quickly |
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| Treatment gave immediate feeling of relief |
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| The medication felt soothing to my skin |
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| The medication was appealing to touch |
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| Treatment felt moisturising to my skin |
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| Treatment not too greasy |
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| Treatment was odourless |
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| Absence of staining of clothes/bed linen |
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| Getting treatment out of container |
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| Container easy to use |
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| Ease of keeping clean container |
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| Dispensing the desired amount |
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