LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2013 |
End Date: | November 2013 |
The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of
treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
Inclusion Criteria:
- A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving
the trunk and/or limbs
- 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)
- An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day
0 (Visit 1)
- A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
- A target lesion of a minimum of 5 cm at its longest axis and preferably not located
on the extensor surface on an elbow or knee, scoring at least 1 for each of redness,
thickness and scaliness, and at least 4 in total by the Investigator's Assessment of
Severity of the Target Lesion
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, infliximab - within 8 weeks prior to randomisation
- ustekinumab - within 16 weeks prior to randomisation
- other products - within 4 weeks/5 half-lives prior to randomisation (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.
- Topical anti-psoriatic treatment on the trunk and limbs (except for emollients)
within 2 weeks prior to randomisation.
- Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D
analogues or prescription shampoos within 2 weeks prior to randomisation.
- Planned initiation of, or changes to, concomitant medication that could affect
psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors)
during the trial.
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Previously randomised in this trial or any previously conducted trial of LEO 90100.
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