Trial Outcomes & Findings for Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris (NCT NCT02310646)

Last Updated: 2025-03-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

2 weeks

Results posted on

2025-03-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
First Intervention (Day 1 - Day 7) STARTED	109	104
First Intervention (Day 1 - Day 7) COMPLETED	107	104
First Intervention (Day 1 - Day 7) NOT COMPLETED	2	0
Second Intervention (Day 8 - Day 14) STARTED	107	104
Second Intervention (Day 8 - Day 14) COMPLETED	107	104
Second Intervention (Day 8 - Day 14) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
First Intervention (Day 1 - Day 7) Withdrawal by Subject	1	0
First Intervention (Day 1 - Day 7) Lost to Follow-up	1	0

Baseline Characteristics

Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foam - Gel n=108 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam n=104 Participants Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Total n=212 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	81 Participants n=7 Participants	162 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	52.1 years STANDARD_DEVIATION 14.0 • n=5 Participants	51.6 years STANDARD_DEVIATION 14.2 • n=7 Participants	51.9 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	34 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	70 Participants n=7 Participants	133 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	All Randomised Subjects n=212 Participants All randomised subjects (foam - gel and gel - foam)	Foam - Gel n=108 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam n=104 Participants Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Prefer Foam - Not at All Important Factor Subjects who prefer foam	Prefer Gel - Very Important Factor Subjects who prefer gel	Prefer Gel - Fairly Important Factor Subjects who prefer gel	Prefer Gel - Not Very Important Factor Subjects who prefer gel	Prefer Gel - Not at All Important Factor Subjects who prefer gel
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	52.9 percentage of subjects	46.2 percentage of 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	47.1 percentage of subjects	53.8 percentage of subjects	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Randomised Subjects n=212 Participants All randomised subjects (foam - gel and gel - foam)	Foam - Gel n=212 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Prefer Foam - Not at All Important Factor Subjects who prefer foam	Prefer Gel - Very Important Factor Subjects who prefer gel	Prefer Gel - Fairly Important Factor Subjects who prefer gel	Prefer Gel - Not Very Important Factor Subjects who prefer gel	Prefer Gel - Not at All Important Factor Subjects who prefer gel
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	1.5 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	1.4 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	1.7 units on a scale Standard Deviation 0.7	—	—	—	—	—	—
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	1.0 units on a scale Standard Deviation 1.2	—	—	—	—	—	—
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	1.4 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	1.5 units on a scale Standard Deviation 0.8	—	—	—	—	—	—
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	1.4 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	1.5 units on a scale Standard Deviation 0.8	—	—	—	—	—	—
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	1.5 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	12.8 units on a scale Standard Deviation 6.1	—	—	—	—	—	—
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	0.7 units on a scale Standard Deviation 1.3	—	—	—	—	—	—
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	0.5 units on a scale Standard Deviation 1.3	—	—	—	—	—	—
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 1.0	0.7 units on a scale Standard Deviation 1.0	—	—	—	—	—	—
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 1.0	1.0 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	0.9 units on a scale Standard Deviation 1.1	—	—	—	—	—	—
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 1.0	1.2 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	0.3 units on a scale Standard Deviation 1.4	—	—	—	—	—	—
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 1.0	1.6 units on a scale Standard Deviation 0.7	—	—	—	—	—	—
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	1.0 units on a scale Standard Deviation 1.3	—	—	—	—	—	—
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	8.0 units on a scale Standard Deviation 7.4	—	—	—	—	—	—
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	1.3 units on a scale Standard Deviation 1.0	—	—	—	—	—	—
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	1.4 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	1.4 units on a scale Standard Deviation 1.0	—	—	—	—	—	—
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	1.5 units on a scale Standard Deviation 0.9	—	—	—	—	—	—
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	5.6 units on a scale Standard Deviation 3.3	—	—	—	—	—	—
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	1.2 units on a scale Standard Deviation 1.0	—	—	—	—	—	—
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	1.3 units on a scale Standard Deviation 1.0	—	—	—	—	—	—
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	1.1 units on a scale Standard Deviation 1.1	—	—	—	—	—	—
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	3.7 units on a scale Standard Deviation 2.9	—	—	—	—	—	—
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	29.9 units on a scale Standard Deviation 16.9	—	—	—	—	—	—
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 1.0	1.2 units on a scale Standard Deviation 1.0	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Randomised Subjects n=118 Participants All randomised subjects (foam - gel and gel - foam)	Foam - Gel n=118 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam n=118 Participants Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Prefer Foam - Not at All Important Factor Subjects who prefer foam	Prefer Gel - Very Important Factor Subjects who prefer gel	Prefer Gel - Fairly Important Factor Subjects who prefer gel	Prefer Gel - Not Very Important Factor Subjects who prefer gel	Prefer Gel - Not at All Important Factor Subjects who prefer 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)	2.8 units on a scale Standard Deviation 7.5	8.3 units on a scale Standard Deviation 7.2	7.5 units on a scale Standard Deviation 8.0	—	—	—	—	—
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	11.5 units on a scale Standard Deviation 6.7	12.5 units on a scale Standard Deviation 6.7	—	—	—	—	—
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	4.6 units on a scale Standard Deviation 3.4	5.5 units on a scale Standard Deviation 3.4	—	—	—	—	—
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 3.0	4.0 units on a scale Standard Deviation 3.0	3.4 units on a scale Standard Deviation 3.2	—	—	—	—	—
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	28.4 units on a scale Standard Deviation 17.1	29.0 units on a scale Standard Deviation 18.6	—	—	—	—	—
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	1.2 units on a scale Standard Deviation 1.0	1.1 units on a scale Standard Deviation 1.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Randomised Subjects n=118 Participants All randomised subjects (foam - gel and gel - foam)	Foam - Gel n=118 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Prefer Foam - Not at All Important Factor Subjects who prefer foam	Prefer Gel - Very Important Factor Subjects who prefer gel	Prefer Gel - Fairly Important Factor Subjects who prefer gel	Prefer Gel - Not Very Important Factor Subjects who prefer gel	Prefer Gel - Not at All Important Factor Subjects who prefer gel
Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)	76.5 percentage of subjects	70.2 percentage of subjects	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Randomised Subjects n=212 Participants All randomised subjects (foam - gel and gel - foam)	Foam - Gel n=212 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Prefer Foam - Not at All Important Factor Subjects who prefer foam	Prefer Gel - Very Important Factor Subjects who prefer gel	Prefer Gel - Fairly Important Factor Subjects who prefer gel	Prefer Gel - Not Very Important Factor Subjects who prefer gel	Prefer Gel - Not at All Important Factor Subjects who prefer gel
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	1.9 units on a scale Standard Deviation 1.4	—	—	—	—	—	—
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	2.0 units on a scale Standard Deviation 1.4	—	—	—	—	—	—
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	1.4 units on a scale Standard Deviation 1.6	—	—	—	—	—	—
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	1.6 units on a scale Standard Deviation 1.4	—	—	—	—	—	—
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	1.9 units on a scale Standard Deviation 1.3	—	—	—	—	—	—
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	1.8 units on a scale Standard Deviation 1.4	—	—	—	—	—	—
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	1.3 units on a scale Standard Deviation 1.6	—	—	—	—	—	—
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	12.0 units on a scale Standard Deviation 7.8	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 2

Population: In total 103 preferred foam and 105 preferred gel. 4 subjects ...

Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)

Outcome measures

Outcome measures
Measure	All Randomised Subjects n=103 Participants All randomised subjects (foam - gel and gel - foam)	Foam - Gel n=103 Participants Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel	Gel - Foam n=103 Participants Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam	Prefer Foam - Not at All Important Factor n=103 Participants Subjects who prefer foam	Prefer Gel - Very Important Factor n=105 Participants Subjects who prefer gel	Prefer Gel - Fairly Important Factor n=105 Participants Subjects who prefer gel	Prefer Gel - Not Very Important Factor n=105 Participants Subjects who prefer gel	Prefer Gel - Not at All Important Factor n=105 Participants Subjects who prefer gel
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	24.3 percentage of subjects	10.7 percentage of subjects	3.9 percentage of subjects	56.2 percentage of subjects	36.2 percentage of subjects	3.8 percentage of subjects	3.8 percentage of 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	30.1 percentage of subjects	12.6 percentage of subjects	5.8 percentage of subjects	54.3 percentage of subjects	37.1 percentage of subjects	4.8 percentage of subjects	3.8 percentage of 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	31.1 percentage of subjects	14.6 percentage of subjects	5.8 percentage of subjects	61.0 percentage of subjects	30.5 percentage of subjects	4.8 percentage of subjects	3.8 percentage of subjects
Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 Easy to spread	65.0 percentage of subjects	24.3 percentage of subjects	4.9 percentage of subjects	5.8 percentage of subjects	52.4 percentage of subjects	41.0 percentage of subjects	2.9 percentage of subjects	3.8 percentage of 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	34.0 percentage of subjects	15.5 percentage of subjects	2.9 percentage of subjects	45.7 percentage of subjects	44.8 percentage of subjects	4.8 percentage of subjects	4.8 percentage of 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	29.9 percentage of subjects	8.2 percentage of subjects	8.2 percentage of subjects	50.5 percentage of subjects	38.4 percentage of subjects	7.1 percentage of subjects	4.0 percentage of 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	25.8 percentage of subjects	5.6 percentage of subjects	6.7 percentage of subjects	44.2 percentage of subjects	44.1 percentage of subjects	10.5 percentage of subjects	3.2 percentage of 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	34.0 percentage of subjects	7.8 percentage of subjects	2.9 percentage of subjects	45.7 percentage of subjects	45.7 percentage of subjects	4.8 percentage of subjects	3.8 percentage of 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	26.2 percentage of subjects	11.7 percentage of subjects	4.9 percentage of subjects	48.6 percentage of subjects	41.9 percentage of subjects	6.7 percentage of subjects	2.9 percentage of subjects
Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 Treatment quickly absorbed	51.5 percentage of subjects	32.0 percentage of subjects	11.7 percentage of subjects	4.9 percentage of subjects	50.5 percentage of subjects	39.0 percentage of subjects	9.5 percentage of subjects	1.0 percentage of subjects
Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 Treatment dried quickly	45.6 percentage of subjects	35.0 percentage of subjects	17.5 percentage of subjects	1.9 percentage of subjects	50.5 percentage of subjects	39.0 percentage of subjects	9.5 percentage of subjects	1.0 percentage of 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	31.1 percentage of subjects	18.4 percentage of subjects	1.9 percentage of subjects	39.0 percentage of subjects	41.0 percentage of subjects	17.1 percentage of subjects	2.9 percentage of 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	36.9 percentage of subjects	8.7 percentage of subjects	3.9 percentage of subjects	46.7 percentage of subjects	39.0 percentage of subjects	12.4 percentage of subjects	1.9 percentage of 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	34.0 percentage of subjects	14.6 percentage of subjects	6.8 percentage of subjects	34.3 percentage of subjects	39.0 percentage of subjects	21.0 percentage of subjects	5.7 percentage of 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	38.8 percentage of subjects	11.7 percentage of subjects	3.9 percentage of subjects	41.0 percentage of subjects	43.8 percentage of subjects	12.4 percentage of subjects	2.9 percentage of 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	30.1 percentage of subjects	17.5 percentage of subjects	3.9 percentage of subjects	43.8 percentage of subjects	38.1 percentage of subjects	15.2 percentage of subjects	2.9 percentage of subjects
Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2 Treatment was odourless	46.6 percentage of subjects	26.2 percentage of subjects	18.4 percentage of subjects	8.7 percentage of subjects	38.1 percentage of subjects	41.0 percentage of subjects	16.2 percentage of subjects	4.8 percentage of 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	31.1 percentage of subjects	11.7 percentage of subjects	3.9 percentage of subjects	54.3 percentage of subjects	36.2 percentage of subjects	7.6 percentage of subjects	1.9 percentage of 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	32.0 percentage of subjects	10.7 percentage of subjects	4.9 percentage of subjects	52.4 percentage of subjects	41.0 percentage of subjects	2.9 percentage of subjects	3.8 percentage of 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	31.1 percentage of subjects	10.7 percentage of subjects	2.9 percentage of subjects	57.1 percentage of subjects	36.2 percentage of subjects	4.8 percentage of subjects	1.9 percentage of 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	33.0 percentage of subjects	16.5 percentage of subjects	7.8 percentage of subjects	45.7 percentage of subjects	38.1 percentage of subjects	16.2 percentage of subjects	0.0 percentage of 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	34.0 percentage of subjects	8.7 percentage of subjects	2.9 percentage of subjects	59.0 percentage of subjects	33.3 percentage of subjects	5.7 percentage of subjects	1.9 percentage of subjects

Adverse Events

Foam - Gel

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Gel - Foam

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 44945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Foam - Gel n=109 participants at risk 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.	Gel - Foam n=104 participants at risk 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.
Infections and infestations Nasopharyngitis	1.8% 2/109 • Number of events 2 • 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.	1.9% 2/104 • Number of events 2 • 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.
Infections and infestations Bronchitis	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Infections and infestations Folliculitis	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Infections and infestations Gastrointestinal infection	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Infections and infestations Oral herpes	0.00% 0/109 • 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.	0.96% 1/104 • Number of events 1 • 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.
Infections and infestations Upper respiratory tract infection	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/109 • 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.	0.96% 1/104 • Number of events 1 • 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Gastrointestinal disorders Nausea	0.00% 0/109 • 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.	0.96% 1/104 • Number of events 1 • 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.
Injury, poisoning and procedural complications Excoriation	0.00% 0/109 • 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.	0.96% 1/104 • Number of events 1 • 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.
Injury, poisoning and procedural complications Ligament rupture	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
General disorders Application site pruritus	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Investigations Arthroscopy	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/109 • 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.	0.96% 1/104 • Number of events 1 • 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.
Nervous system disorders Headache	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/109 • 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.	0.96% 1/104 • Number of events 1 • 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.
Vascular disorders Hypertension	0.92% 1/109 • Number of events 1 • 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.	0.00% 0/104 • 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.