LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

Completed · Phase 2

Conditions studied: Psoriasis Vulgaris

In brief

The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.

Key facts

Study ID

NCT01536886

Run by

LEO Pharma

People needed

376

Starts

2012-05-01

Expected to finish

2012-11-01

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• Skin Surgery Medical Group, Inc — San Diego, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• About Skin Dermatology and DermSurgery, PC — Denver, Colorado, United States
• Colorado Medical Research Center, Inc — Denver, Colorado, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• Dermatology Associates and Research — Coral Gables, Florida, United States
• North Florida Dermatology Associates, PA — Jacksonville, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Ameriderm Research — Ormond Beach, Florida, United States
• Gwinnett Clinical Research Ctr, Inc — Snellville, Georgia, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Glazer Dermatology — Buffalo Grove, Illinois, United States
• Clinical Research Advantage, Inc./Hudson Dermatology, LLC — Evansville, Indiana, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Owensboro Dermatology Associates — Owensboro, Kentucky, United States
• David Fivenson, MD, PLC — Ann Arbor, Michigan, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Derm Center — Troy, Michigan, United States
• Grekin Skin Institute — Warren, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States

Full record on ClinicalTrials.gov

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