Psoriasis VulgarisPhase 2NCT01536886
LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
A Phase 2 study testing LEO 90100 and Betamethasone plus calcipotriol in people with Psoriasis Vulgaris, run by LEO Pharma at 39 sites in United States.
Trial summary
The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90100 and Betamethasone plus calcipotriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 39 sitesUnited States
- Study dates
- May 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Glazer Dermatology
Buffalo Grove, Illinois, 60089
Dermatology Associates and Research
Coral Gables, Florida, 33134
Menter Dermatology Research Institute
Dallas, Texas, 75246
About Skin Dermatology and DermSurgery, PC
Denver, Colorado, 80113
Colorado Medical Research Center, Inc
Denver, Colorado, 80210
Horizons Clinical Research Center
Denver, Colorado, 80220
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520
Clinical Research Advantage, Inc./Hudson Dermatology, LLC
Evansville, Indiana, 47714
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056
Center for Clinical Studies
Houston, Texas, 77065
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
Dermatology Research Associates
Los Angeles, California, 90045
International Dermatology Research, Inc.
Miami, Florida, 33144
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Specialists, Inc.
Oceanside, California, 92056
Ameriderm Research
Ormond Beach, Florida, 32174
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Progressive Clinical Research
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc
San Diego, California, 92117
University Clinical Trials, Inc.
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Gwinnett Clinical Research Ctr, Inc
Snellville, Georgia, 30078
Premier Clinical Research
Spokane, Washington, 99204
Derm Research Center of New York
Stony Brook, New York, 11790
Derm Center
Troy, Michigan, 48084
The Dermatology Group, PC
Verona, New Jersey, 07044
Grekin Skin Institute
Warren, Michigan, 48008
About this study
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.
The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100, Betamethasone plus calcipotriol, Ointment vehicle, LEO 90100 vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100Drug
Betamethasone plus calcipotriolDrug
Ointment vehicleDrug
LEO 90100 vehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 vehicle | Placebo comparator | Aerosol foam with no active ingredient Receives: Drug: LEO 90100 vehicle |
| Betamethasone plus calcipotriol | Active comparator | Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment Receives: Drug: Betamethasone plus calcipotriol |
| LEO 90100 | Experimental | LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Receives: Drug: LEO 90100 |
| Ointment vehicle | Placebo comparator | Ointment with no active ingredients Receives: Drug: Ointment vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Koo, MD, Principal investigator, University of California, San Francisco School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536886
- Sponsor's protocol ID
- LEO 90100-35
- Status last verified
- Aug 2016
- First submitted
- 16 Feb 2012
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
Iversen 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.
PubMed 32785881
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01536886
- Acronym / sponsor ID
- LEO 90100-35
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Posted 9 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 vehicle | Placebo comparator | Drug: LEO 90100 vehicleAerosol foam with no active ingredient |
| Betamethasone plus calcipotriol | Active comparator | Drug: Betamethasone plus calcipotriolCalcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment |
| LEO 90100 | Experimental | Drug: LEO 90100LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) |
| Ointment vehicle | Placebo comparator | Drug: Ointment vehicleOintment with no active ingredients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 90100 | Drug | LEO 90100 |
| Betamethasone plus calcipotriol | Drug | Betamethasone plus calcipotriol |
| Ointment vehicle | Drug | Ointment vehicle |
| LEO 90100 vehicle | Drug | LEO 90100 vehicle |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundKoo 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.
- Derived from this study: PubMed 32785881Iversen 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.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Koo, MD principal investigator
University of California, San Francisco School of Medicine
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 90100 and Betamethasone plus calcipotriol in people with Psoriasis Vulgaris, run by LEO Pharma at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01536886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.