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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


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

Page last updated: August 23, 2015

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