Back to resultsPatient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
LEO 90100 Aerosol Foam
Daivobet® gel
Sponsored by
About this trial
This is an interventional other trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion:
- 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
- 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)
- A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1)
- A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1)
Exclusion:
- Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation.
- Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel).
- Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation.
- Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation.
- 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.
- 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.
- Previously randomised into a clinical trial involving LEO 90100.
- Current participation in any other interventional clinical trial.
- Previously randomised into this trial.
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- 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.
- Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
- Known or suspected severe renal insufficiency or severe hepatic disorders.
Sites / Locations
- K.Papp Clinical Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment group 1
Treatment group 2
Arm Description
Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02310646
Brief Title
Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
Official Title
A Clinical Trial Gathering Insight of Patient Reported Factors That Influence Preference Following Once Daily Topical Treatment With LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group 1
Arm Type
Active Comparator
Arm Description
Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
Arm Title
Treatment group 2
Arm Type
Active Comparator
Arm Description
Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
Intervention Type
Drug
Intervention Name(s)
LEO 90100 Aerosol Foam
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Daivobet® gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics
Description
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
Other Pre-specified Outcome Measures:
Title
Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments
Description
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
Title
Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments
Description
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
Title
Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)
Description
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
Title
Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments
Description
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
Title
Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2
Description
Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)
Time Frame
Baseline to Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
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
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)
A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1)
A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1)
Exclusion:
Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation.
Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel).
Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation.
Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation.
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.
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.
Previously randomised into a clinical trial involving LEO 90100.
Current participation in any other interventional clinical trial.
Previously randomised into this trial.
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
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.
Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis.
Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
Known or suspected severe renal insufficiency or severe hepatic disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Papp, MD phD
Organizational Affiliation
K. Papp Clinical Research INC.
Official's Role
Principal Investigator
Facility Information:
Facility Name
K.Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1CR
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
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