Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004759-30 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP0113 aerosol spray | Active Comparator | Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical |
|
| Aerosol spray vehicle | Placebo Comparator | No active ingredient, topical |
|
| LEO 90100 aerosol foam | Active Comparator | Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical |
|
| Betamethasone dipropionate aerosol spray | Active Comparator | Betamethasone (as dipropionate) 0.5 mg/g, topical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP0113 aerosol spray | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) | End of treatment compared to baseline - 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in single clinical sign score: erythema, scaling, infiltration | End of treatment and individual visits compared to baseline - 4 weeks | |
| Absolute Change in Total Clinical Score (TCS) | Individual visits compared to baseline - 4 weeks |
Not provided
Inclusion Criteria:
Signed and dated informed consent has been obtained
Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
Age 18 years or above
Outpatients
Female subjects must be of either
Exclusion Criteria:
Female subjects who are breast feeding
Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) | Nice | 06000 | France |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Calcipotriol aerosol spray |
| Active Comparator |
Calcipotriol (as monohydrate) 50 mcg/g, topical |
|
| Daivobet® gel | Active Comparator | Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical |
|
| Aerosol spray vehicle | Drug |
|
| LEO 90100 aerosol foam | Drug |
|
| Betamethasone dipropionate aerosol spray | Drug |
|
| Calcipotriol aerosol spray | Drug |
|
| Daivobet® gel | Drug |
|
| Absolute change in total skin thickness and echo-poor band thickness | End of treatment compared to baseline - 4 weeks |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000088342 | Aerosolized Particles and Droplets |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
Not provided
Not provided