Psoriasis Vulgaris
Conditions
Brief summary
The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.
Interventions
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent obtained prior to any trial related activities (including washout period). * Age 18 years or above * Either sex * Any race or ethnicity * All skin types * Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1). * Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year). * Able to communicate with the investigator and understand and comply with the requirements of the study.
Exclusion criteria
* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: * etanercept - within 4 weeks prior to randomisation * adalimumab, alefacept, infliximab - within 8 weeks prior to randomisation * ustekinumab - within 16 weeks prior to randomisation * other products - 4 weeks/5 half-lives (whichever is longer) * Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation. * Subjects who have received treatment with any nonmarketed 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. * PUVA therapy within 4 weeks prior to randomisation. * 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 study. * Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study. * 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, icthyosis, 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 vulgaris. * Known or suspected disorders of calcium metabolism associated with hypercalcaemia. * Known or suspected severe renal insufficiency or severe hepatic disorders. * Known or suspected hypersensitivity to component(s) of the investigational products. * Current participation in any other interventional clinical study. * Previously randomised in this study. * Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. | 4 weeks | Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation. |
Countries
United States
Participant flow
Recruitment details
First Subject First Visit: 10-May-2012 Last Subject Last Visit: 19-Sep-2012
Pre-assignment details
Prior to random., the subjects entered a washout phase (if required) where antipsoriatic treatm. and other relevant medication/treatms. had to be discontinued as defined by the excl. criteria. Depending on prior use of disallowed treatms, the washout/screening phase could last for up to 4 w prior to the first admin. of investigational products.
Participants by arm
| Arm | Count |
|---|---|
| LEO 90100 LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) | 141 |
| Calcipotriol Plus BDP Ointment Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment | 135 |
| LEO 90100 Vehicle Aerosol foam with no active ingredients | 49 |
| Ointment Vehicle Ointment with no active ingredients | 51 |
| Total | 376 |
Baseline characteristics
| Characteristic | LEO 90100 | Calcipotriol Plus BDP Ointment | LEO 90100 Vehicle | Ointment Vehicle | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 12.9 | 50.6 years STANDARD_DEVIATION 13.1 | 45.8 years STANDARD_DEVIATION 13.7 | 52.6 years STANDARD_DEVIATION 11.1 | 50.4 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 54 Participants | 48 Participants | 19 Participants | 21 Participants | 142 Participants |
| Sex: Female, Male Male | 87 Participants | 87 Participants | 30 Participants | 30 Participants | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 141 | 0 / 134 | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 141 | 1 / 134 | 0 / 49 | 0 / 51 |
Outcome results
Primary
Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 90100 | Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. | 77 participants |
| Calcipotriol Plus BDP Ointment | Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. | 58 participants |
| LEO 90100 Vehicle | Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. | 3 participants |
| Ointment Vehicle | Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. | 4 participants |