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

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ClinicalTrials.gov Identifier: NCT01536886
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : December 9, 2015
Last Update Posted : September 19, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 90100 Drug: Betamethasone plus calcipotriol Drug: Ointment vehicle Drug: LEO 90100 vehicle Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Comparing Treatment With LEO 90100 With Calcipotriol Plus Betamethasone Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris.
Study Start Date : May 2012
Primary Completion Date : September 2012
Study Completion Date : November 2012

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: LEO 90100 vehicle
Aerosol foam with no active ingredient
Drug: LEO 90100 vehicle
Active Comparator: Betamethasone plus calcipotriol
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
Drug: Betamethasone plus calcipotriol
Experimental: LEO 90100
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Drug: LEO 90100
Placebo Comparator: Ointment vehicle
Ointment with no active ingredients
Drug: Ointment vehicle

Outcome Measures

Primary Outcome Measures :
  1. Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. [ Time Frame: 4 weeks ]
    Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536886

  Hide Study Locations
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Dermatology Specialists, Inc.
Oceanside, California, United States, 92056
Skin Surgery Medical Group, Inc
San Diego, California, United States, 92117
University Clinical Trials, Inc.
San Diego, California, United States, 92123
Clinical Science Institute
Santa Monica, California, United States, 90404
United States, Colorado
About Skin Dermatology and DermSurgery, PC
Denver, Colorado, United States, 80113
Colorado Medical Research Center, Inc
Denver, Colorado, United States, 80210
Horizons Clinical Research Center
Denver, Colorado, United States, 80220
United States, Florida
Dermatology Associates and Research
Coral Gables, Florida, United States, 33134
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
Ameriderm Research
Ormond Beach, Florida, United States, 32174
United States, Georgia
Gwinnett Clinical Research Ctr, Inc
Snellville, Georgia, United States, 30078
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Clinical Research Advantage, Inc./Hudson Dermatology, LLC
Evansville, Indiana, United States, 47714
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States, 46256
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Kentucky
Owensboro Dermatology Associates
Owensboro, Kentucky, United States, 42303
United States, Michigan
David Fivenson, MD, PLC
Ann Arbor, Michigan, United States, 48103
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
Derm Center
Troy, Michigan, United States, 48084
Grekin Skin Institute
Warren, Michigan, United States, 48008
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Jersey
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States, 08520
The Dermatology Group, PC
Verona, New Jersey, United States, 07044
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106-5239
United States, New York
Derm Research Center of New York
Stony Brook, New York, United States, 11790
United States, Pennsylvania
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, United States, 77056
Center for Clinical Studies
Houston, Texas, United States, 77065
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
Progressive Clinical Research
San Antonio, Texas, United States, 78229
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84117
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
LEO Pharma
Principal Investigator: John Koo, MD University of California, San Francisco School of Medicine
More Information

Additional Information:
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01536886     History of Changes
Other Study ID Numbers: LEO 90100-35
First Posted: February 22, 2012    Key Record Dates
Results First Posted: December 9, 2015
Last Update Posted: September 19, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents