Skin and Connective Tissue Diseases
Conditions
Keywords
Psoriasis
Brief summary
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.
Interventions
DRUGLP0113 aerosol spray
DRUGAerosol spray vehicle
DRUGBetamethasone dipropionate aerosol spray
DRUGCalcipotriol aerosol spray
DRUGDaivobet® gel
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, * child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
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: * Etanercept - within 4 weeks prior to randomisation and during the trial * Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial * Ustekinumab - within 16 weeks prior to randomisation and during the trial * Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer) * 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: * PUVA: 4 weeks * UVB: 2 weeks * 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: * Potent or very potent (WHO group III-IV) corticosteroids * Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial: * WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis) * Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid * 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Absolute change in total skin thickness and echo-poor band thickness | End of treatment compared to baseline - 4 weeks |
Countries
France
Outcome results
None listed