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

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
1
site
St. Louis, Missouri 63117
?
mi
from
St. Louis, MO
Click here to add this to my saved trials