LEO 90100 in the Treatment of Psoriasis Vulgaris
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2012 |
End Date: | November 2012 |
The purpose of this study is to investigate whether LEO 90100, calcipotriol and
betamethasone are effective in the treatment of psoriasis vulgaris.
betamethasone are effective in the treatment of psoriasis vulgaris.
Inclusion Criteria:
- Signed and dated informed consent obtained prior to any trial related activities
(including washout period).
- Age 18 years or above
- Either sex
- Any race or ethnicity
- All skin types
- Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit
1).
- Females of childbearing potential must agree to use a highly effective method of
birth control during the study. A highly effective method of birth control is defined
as one which results in a low failure rate (less than 1% per year).
- Able to communicate with the investigator and understand and comply with the
requirements of the study.
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, alefacept, infliximab - within 8 weeks prior to randomisation
- ustekinumab - within 16 weeks prior to randomisation
- other products - 4 weeks/5 half-lives (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.
- Planned excessive exposure of area(s) to be treated with study medication to either
natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the
study.
- Planned initiation of, or changes to, concomitant medication that could affect
psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors)
during the study.
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Subjects with any of the following conditions present on the treatment area: viral
(e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections,
parasitic infections, skin manifestations in relation to syphilis or tuberculosis,
acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis,
ulcers and wounds.
- Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis)
on the treatment area that may confound the evaluation of psoriasis vulgaris.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
- Known or suspected severe renal insufficiency or severe hepatic disorders.
- Known or suspected hypersensitivity to component(s) of the investigational products.
- Current participation in any other interventional clinical study.
- Previously randomised in this study.
- Females who are pregnant, wishing to become pregnant during the study, or are
breast-feeding.
We found this trial at
33
sites
7810 Louis Pasteur
San Antonio, Texas 78229
San Antonio, Texas 78229
210-692-1382
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