Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
303 participants
INTERVENTIONAL
2012-05-31
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
NCT01536886
LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
NCT02132936
LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
NCT01866163
The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris
NCT01768013
LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)
NCT01188928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Calcipotriol
Calcipotriol aerosol foam: calcipotriol 50 mcg/g.
Applied once daily for up to 4 weeks
Calcipotriol
Betamethasone
Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)
Applied once daily for up to 4 weeks
Betamethasone
LEO 90100
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Applied once daily for up to 4 weeks
LEO 90100
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LEO 90100
Calcipotriol
Betamethasone
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LEO Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Lebwohl, M.D.
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States
The Dermatology Group, PC
Verona, New Jersey, United States
Derm Research Center of New York
Stony Brook, New York, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study. J Clin Aesthet Dermatol. 2016 Feb;9(2):34-41. Epub 2016 Feb 1.
Veverka KA, Hansen JB, Yaloumis M, Kircik L, Stein Gold L. Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials. J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at LEO Pharma
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LEO 90100-7
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.