Psoriasis Vulgaris
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGDaivobet® 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.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. At Day 1 (Visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs amenable to treatment with a maximum of 60 g of study medication per week 2. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA) at Day 1 (Visit 1) 3. A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1) 4. A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1) Exclusion: 1. Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation. 2. Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel). 3. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation. 4. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation. 5. Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps etc.) during the trial. 6. Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation. 7. Previously randomised into a clinical trial involving LEO 90100. 8. Current participation in any other interventional clinical trial. 9. Previously randomised into this trial. 10. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 11. Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ulcers and wounds. 12. Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis. 13. Known or suspected disorders of calcium metabolism associated with hypercalcaemia. 14. Known or suspected severe renal insufficiency or severe hepatic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | 2 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 2 weeks | 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. |
| Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Baseline to Week 2 | 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. |
| Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel) | At Week 1 and Week 2 | 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. |
| Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | At Week 1 and Week 2 | 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. |
| Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Baseline to Week 2 | Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel) |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Foam - Gel Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel | 108 |
| Gel - Foam Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam | 104 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (Day 1 - Day 7) | Lost to Follow-up | 1 | 0 |
| First Intervention (Day 1 - Day 7) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Foam - Gel | Gel - Foam | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 23 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 81 Participants | 162 Participants |
| Age, Continuous | 52.1 years STANDARD_DEVIATION 14 | 51.6 years STANDARD_DEVIATION 14.2 | 51.9 years STANDARD_DEVIATION 14.1 |
| Sex: Female, Male Female | 45 Participants | 34 Participants | 79 Participants |
| Sex: Female, Male Male | 63 Participants | 70 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 109 | 8 / 104 |
| serious Total, serious adverse events | 0 / 109 | 0 / 104 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Randomised Subjects | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | Overall, I preferred the aerosol foam | 49.5 percentage of subjects |
| All Randomised Subjects | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | Overall, I preferred the gel in a bottle | 50.5 percentage of subjects |
| Foam - Gel | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | Overall, I preferred the aerosol foam | 52.9 percentage of subjects |
| Foam - Gel | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | Overall, I preferred the gel in a bottle | 47.1 percentage of subjects |
| Gel - Foam | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | Overall, I preferred the aerosol foam | 46.2 percentage of subjects |
| Gel - Foam | Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | Overall, I preferred the gel in a bottle | 53.8 percentage of subjects |
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female).p-value: 0.2Regression, Logistic
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years).p-value: =0.001Regression, Logistic
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe).p-value: 0.29Regression, Logistic
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread).p-value: 0.55Regression, Logistic
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, \>3 mm diameter).p-value: 0.25Regression, Logistic
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, \>0.75 mm).p-value: 0.41Regression, Logistic
Comparison: The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, \>40 years of age).p-value: 0.2Regression, Logistic
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)
Time frame: Baseline to Week 2
Population: In total 103 preferred foam and 105 preferred gel. 4 subjects ...
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 48.5 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 52.4 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 47.6 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 45.6 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 48.5 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 54.4 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 61.8 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 57.3 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 53.4 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 51.5 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 53.6 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 48.5 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 46.6 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 42.7 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 44.7 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 51.5 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 65.0 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 61.2 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 45.6 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 50.5 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 55.3 percentage of subjects |
| All Randomised Subjects | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 55.3 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 24.3 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 31.1 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 31.1 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 35.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 32.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 33.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 31.1 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 24.3 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 30.1 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 32.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 34.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 31.1 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 29.9 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 34.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 26.2 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 25.8 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 30.1 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 38.8 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 34.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 34.0 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 26.2 percentage of subjects |
| Foam - Gel | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 36.9 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 8.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 15.5 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 11.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 10.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 10.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 11.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 7.8 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 16.5 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 4.9 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 14.6 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 18.4 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 10.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 12.6 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 17.5 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 18.4 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 11.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 8.2 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 17.5 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 11.7 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 14.6 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 5.6 percentage of subjects |
| Gel - Foam | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 8.7 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 8.7 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 5.8 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 5.8 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 5.8 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 2.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 8.2 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 6.7 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 2.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 4.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 3.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 4.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 1.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 1.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 3.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 6.8 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 3.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 3.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 3.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 4.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 2.9 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 7.8 percentage of subjects |
| Prefer Foam - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 2.9 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 39.0 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 45.7 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 45.7 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 61.0 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 50.5 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 46.7 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 41.0 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 50.5 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 56.2 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 54.3 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 52.4 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 44.2 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 45.7 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 54.3 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 43.8 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 52.4 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 34.3 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 57.1 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 48.6 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 59.0 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 50.5 percentage of subjects |
| Prefer Gel - Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 38.1 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 33.3 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 41.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 38.1 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 44.8 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 41.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 36.2 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 39.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 41.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 39.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 41.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 45.7 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 39.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 39.0 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 36.2 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 37.1 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 43.8 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 30.5 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 44.1 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 36.2 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 38.1 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 41.9 percentage of subjects |
| Prefer Gel - Fairly Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 38.4 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 21.0 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 16.2 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 17.1 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 6.7 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 12.4 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 4.8 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 4.8 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 10.5 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 12.4 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 15.2 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 7.1 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 16.2 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 4.8 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 7.6 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 2.9 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 2.9 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 4.8 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 4.8 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 5.7 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 9.5 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 3.8 percentage of subjects |
| Prefer Gel - Not Very Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 9.5 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment dried quickly | 1.0 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying the medication was not messy | 4.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment not too greasy | 2.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for smaller areas | 4.0 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Ease of keeping clean container | 0.0 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Container easy to use | 1.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment felt moisturising to my skin | 2.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Overall good for larger areas | 3.2 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was easy to apply | 3.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment gave immediate feeling of relief | 2.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication was appealing to touch | 5.7 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was quick to apply | 3.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Total time spent on treatment acceptable | 2.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment quickly absorbed | 1.0 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | The medication felt soothing to my skin | 1.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy to spread | 3.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Absence of staining of clothes/bed linen | 1.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Dispensing the desired amount | 1.9 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Applying treatment easy in daily routine | 3.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Getting treatment out of container | 3.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Treatment was odourless | 4.8 percentage of subjects |
| Prefer Gel - Not at All Important Factor | Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 | Easy application on psoriasis lesions only | 3.8 percentage of subjects |
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.
Time frame: At Week 1 and Week 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Randomised Subjects | Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel) | 76.5 percentage of subjects |
| Foam - Gel | Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel) | 70.2 percentage of subjects |
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.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 1. Ease of application | 1.1 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 2. Ease of application on psoriasis lesions only | 0.9 units on a scale | Standard Deviation 1.3 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 3. Ease of spreading | 1.5 units on a scale | Standard Deviation 0.8 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 4. Lack of mess when applying | 0.8 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 5. Good for use on smaller areas | 1.0 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 6. Good for use on larger areas | 1.4 units on a scale | Standard Deviation 0.9 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 7. Quick to apply | 1.4 units on a scale | Standard Deviation 0.8 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 8. Total time spent acceptable | 1.5 units on a scale | Standard Deviation 0.7 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 9. Easily incorporated into daily routine | 1.4 units on a scale | Standard Deviation 0.9 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total application score (summary score item 1-9) | 11.1 units on a scale | Standard Deviation 6.9 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 10. Quickly absorbed | 0.7 units on a scale | Standard Deviation 1.3 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 11. Dried quickly | 0.5 units on a scale | Standard Deviation 1.3 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 12. Gave an immediate feeling of relief | 1.0 units on a scale | Standard Deviation 1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 13. Felt soothing to my skin | 1.2 units on a scale | Standard Deviation 1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 14. Appealing to touch | 0.9 units on a scale | Standard Deviation 1.1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 15. Felt moisturising to my skin | 1.1 units on a scale | Standard Deviation 1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 16. Not greasy | 0.0 units on a scale | Standard Deviation 1.5 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 17. Odourless | 1.3 units on a scale | Standard Deviation 1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 18. Lack of staining of clothes/bed linen | 1.0 units on a scale | Standard Deviation 1.3 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total formulation score (summary score item 10-18) | 7.7 units on a scale | Standard Deviation 7.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 19. Easy to get medication out of container | 1.1 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 20. Easy to use container | 1.1 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 21. Easy to keep container clean | 1.2 units on a scale | Standard Deviation 1.1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 22. Accurately dispense wanted amount | 0.9 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total container score (summary score item 19-22) | 4.3 units on a scale | Standard Deviation 3.8 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 23. Confidence in using the product | 1.2 units on a scale | Standard Deviation 1.1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 24. Would regularly use the product | 1.3 units on a scale | Standard Deviation 1.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 25. Would recommend the product | 1.2 units on a scale | Standard Deviation 1.1 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total satisfaction score(summary score item 23-25) | 3.6 units on a scale | Standard Deviation 3.2 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total TPUQ score (summary score item 1-25) | 26.8 units on a scale | Standard Deviation 17.8 |
| All Randomised Subjects | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 26. Overall satisfaction score | 1.1 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 15. Felt moisturising to my skin | 1.2 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 1. Ease of application | 1.5 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 22. Accurately dispense wanted amount | 1.5 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 2. Ease of application on psoriasis lesions only | 1.4 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 16. Not greasy | 0.3 units on a scale | Standard Deviation 1.4 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 3. Ease of spreading | 1.7 units on a scale | Standard Deviation 0.7 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 25. Would recommend the product | 1.1 units on a scale | Standard Deviation 1.1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 4. Lack of mess when applying | 1.0 units on a scale | Standard Deviation 1.2 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 17. Odourless | 1.6 units on a scale | Standard Deviation 0.7 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 5. Good for use on smaller areas | 1.4 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total container score (summary score item 19-22) | 5.6 units on a scale | Standard Deviation 3.3 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 6. Good for use on larger areas | 1.5 units on a scale | Standard Deviation 0.8 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 18. Lack of staining of clothes/bed linen | 1.0 units on a scale | Standard Deviation 1.3 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 7. Quick to apply | 1.4 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total TPUQ score (summary score item 1-25) | 29.9 units on a scale | Standard Deviation 16.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 8. Total time spent acceptable | 1.5 units on a scale | Standard Deviation 0.8 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total formulation score (summary score item 10-18) | 8.0 units on a scale | Standard Deviation 7.4 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 9. Easily incorporated into daily routine | 1.5 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 23. Confidence in using the product | 1.2 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total application score (summary score item 1-9) | 12.8 units on a scale | Standard Deviation 6.1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 19. Easy to get medication out of container | 1.3 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 10. Quickly absorbed | 0.7 units on a scale | Standard Deviation 1.3 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | Total satisfaction score(summary score item 23-25) | 3.7 units on a scale | Standard Deviation 2.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 11. Dried quickly | 0.5 units on a scale | Standard Deviation 1.3 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 20. Easy to use container | 1.4 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 12. Gave an immediate feeling of relief | 0.7 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 24. Would regularly use the product | 1.3 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 13. Felt soothing to my skin | 1.0 units on a scale | Standard Deviation 0.9 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 21. Easy to keep container clean | 1.4 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 14. Appealing to touch | 0.9 units on a scale | Standard Deviation 1.1 |
| Foam - Gel | Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments | 26. Overall satisfaction score | 1.2 units on a scale | Standard Deviation 1 |
Comparison: Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.p-value: 0.007Wilcoxon Rank Sum Test
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.
Time frame: Baseline to Week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Randomised Subjects | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total application score (sum score items 1-9) | 9.9 units on a scale | Standard Deviation 6.7 |
| All Randomised Subjects | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total formulation score (sum score items 10-18) | 2.8 units on a scale | Standard Deviation 7.5 |
| All Randomised Subjects | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total container score (sum score items 19-22) | 4.6 units on a scale | Standard Deviation 3.7 |
| All Randomised Subjects | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total satisfaction score (sum score items 23-25) | 2.0 units on a scale | Standard Deviation 3 |
| All Randomised Subjects | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total TPUQ score (items 1-25) | 19.4 units on a scale | Standard Deviation 16.9 |
| All Randomised Subjects | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | 26. Overall satisfaction score | 0.3 units on a scale | Standard Deviation 1.1 |
| Foam - Gel | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | 26. Overall satisfaction score | 1.2 units on a scale | Standard Deviation 1 |
| Foam - Gel | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total application score (sum score items 1-9) | 11.5 units on a scale | Standard Deviation 6.7 |
| Foam - Gel | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total satisfaction score (sum score items 23-25) | 4.0 units on a scale | Standard Deviation 3 |
| Foam - Gel | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total TPUQ score (items 1-25) | 28.4 units on a scale | Standard Deviation 17.1 |
| Foam - Gel | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total formulation score (sum score items 10-18) | 8.3 units on a scale | Standard Deviation 7.2 |
| Foam - Gel | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total container score (sum score items 19-22) | 4.6 units on a scale | Standard Deviation 3.4 |
| Gel - Foam | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total formulation score (sum score items 10-18) | 7.5 units on a scale | Standard Deviation 8 |
| Gel - Foam | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total container score (sum score items 19-22) | 5.5 units on a scale | Standard Deviation 3.4 |
| Gel - Foam | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | 26. Overall satisfaction score | 1.1 units on a scale | Standard Deviation 1.1 |
| Gel - Foam | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total satisfaction score (sum score items 23-25) | 3.4 units on a scale | Standard Deviation 3.2 |
| Gel - Foam | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total application score (sum score items 1-9) | 12.5 units on a scale | Standard Deviation 6.7 |
| Gel - Foam | Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments | Total TPUQ score (items 1-25) | 29.0 units on a scale | Standard Deviation 18.6 |
Comparison: 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 foam versus latest topical treatment.p-value: <0.001Wilcoxon Signed Rank Test
Comparison: 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.p-value: <0.001Wilcoxon Signed Rank Test
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.
Time frame: At Week 1 and Week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | Ease of application | 1.5 units on a scale | Standard Deviation 1.7 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | Time it takes to apply | 1.9 units on a scale | Standard Deviation 1.4 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How well it is absorbed | 1.4 units on a scale | Standard Deviation 1.6 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How it feels to touch | 1.4 units on a scale | Standard Deviation 1.6 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How it smells | 1.6 units on a scale | Standard Deviation 1.5 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How it feels on the skin | 1.8 units on a scale | Standard Deviation 1.5 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How much it stains | 1.4 units on a scale | Standard Deviation 1.5 |
| All Randomised Subjects | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | Total VPM score (summary score) | 11.1 units on a scale | Standard Deviation 7.8 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | Total VPM score (summary score) | 12.0 units on a scale | Standard Deviation 7.8 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | Ease of application | 1.9 units on a scale | Standard Deviation 1.4 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How it smells | 1.9 units on a scale | Standard Deviation 1.3 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | Time it takes to apply | 2.0 units on a scale | Standard Deviation 1.4 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How much it stains | 1.3 units on a scale | Standard Deviation 1.6 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How well it is absorbed | 1.4 units on a scale | Standard Deviation 1.6 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How it feels on the skin | 1.8 units on a scale | Standard Deviation 1.4 |
| Foam - Gel | Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments | How it feels to touch | 1.6 units on a scale | Standard Deviation 1.4 |