LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
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.
1 other identifier
interventional
376
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
December 9, 2015
CompletedMarch 7, 2025
August 1, 2016
4 months
February 16, 2012
November 2, 2015
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
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.
4 weeks
Study Arms (4)
LEO 90100 vehicle
PLACEBO COMPARATORAerosol foam with no active ingredient
Betamethasone plus calcipotriol
ACTIVE COMPARATORCalcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
LEO 90100
EXPERIMENTALLEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Ointment vehicle
PLACEBO COMPARATOROintment with no active ingredients
Interventions
Eligibility Criteria
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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (39)
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
About Skin Dermatology and DermSurgery, PC
Denver, Colorado, 80113, 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
Ameriderm Research
Ormond Beach, Florida, 32174, United States
Gwinnett Clinical Research Ctr, Inc
Snellville, Georgia, 30078, 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
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239, 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
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056, 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
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Related Publications (2)
Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, Bagel J. Superior efficacy of the fixed combination calcipotriene plus betamethasone dipropionate in a novel aerosol foam versus ointment in patients with psoriasis vulgaris. Semin Cutan Med Surg. 2015;34 S1:PA-42.
BACKGROUNDIversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12.
PMID: 32785881DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure Manager
- Organization
- LEO Pharma A/S
Study Officials
- PRINCIPAL INVESTIGATOR
John Koo, MD
University of California, San Francisco School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2012
Study Completion
November 1, 2012
Last Updated
March 7, 2025
Results First Posted
December 9, 2015
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share