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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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