LEO 90100 in the Treatment of Psoriasis Vulgaris
Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis Vulgaris
Intervention: LEO 90100 (Drug); Calcipotriol (Drug); Betamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: LEO Pharma Official(s) and/or principal investigator(s):
Mark Lebwohl, M.D., Principal Investigator, Affiliation: Mount Sinai Hospital, New York
Summary
The purpose of this study is to investigate whether LEO 90100, calcipotriol and
betamethasone are effective in the treatment of psoriasis vulgaris.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Investigator's global assessment of disease severity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States
Dermatology Research Associates, Los Angeles, California 90045, United States
Dermatology Specialists, Inc., Oceanside, California 92056, United States
Skin Surgery Medical Group, Inc, San Diego, California 92117, United States
University Clinical Trials, Inc., San Diego, California 92123, United States
Clinical Science Institute, Santa Monica, California 90404, United States
Colorado Medical Research Center, Inc, Denver, Colorado 80210, United States
Horizons Clinical Research Center, Denver, Colorado 80220, United States
Dermatology Associates and Research, Coral Gables, Florida 33134, United States
North Florida Dermatology Associates, PA, Jacksonville, Florida 32204, United States
International Dermatology Research, Inc., Miami, Florida 33144, United States
Altman Dermatology Associates, Arlington Heights, Illinois 60005, United States
Glazer Dermatology, Buffalo Grove, Illinois 60089, United States
Clinical Research Advantage, Inc./Hudson Dermatology, LLC, Evansville, Indiana 47714, United States
Dawes Fretzin Clinical Research Group, Indianapolis, Indiana 46256, United States
The Indiana Clinical Trials Center, Plainfield, Indiana 46168, United States
Owensboro Dermatology Associates, Owensboro, Kentucky 42303, United States
David Fivenson, MD, PLC, Ann Arbor, Michigan 48103, United States
Great Lakes Research Group, Inc., Bay City, Michigan 48706, United States
Derm Center, Troy, Michigan 48084, United States
Grekin Skin Institute, Warren, Michigan 48008, United States
Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States
Psoriasis Treatment Center of Central NJ, East Windsor, New Jersey 08520, United States
The Dermatology Group, PC, Verona, New Jersey 07044, United States
Derm Research Center of New York, Stony Brook, New York 11790, United States
Philadelphia Institute of Dermatology, Fort Washington, Pennsylvania 19034, United States
Menter Dermatology Research Institute, Dallas, Texas 75246, United States
Center for Clinical Studies, Houston, Texas 77065, United States
Clinical Trials of Texas, Inc, San Antonio, Texas 78229, United States
Dermatology Clinical Research Center of San Antonio, San Antonio, Texas 78229, United States
Progressive Clinical Research, San Antonio, Texas 78229, United States
Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States
Premier Clinical Research, Spokane, Washington 99204, United States
Additional Information
Related publications: Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. A novel aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal and BD foam alone in treating psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, Phase II study. J Am Acad Dermatol. 2015:72 Suppl 1;AB222 (P1670).
Starting date: May 2012
Last updated: July 17, 2015
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