Psoriasis VulgarisPhase 3NCT01866163
LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
A Phase 3 study testing LEO 90100 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United States.
Trial summary
The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Nov 2013
- Phase
- Phase 3
- 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
- A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
- Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
- An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
- A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
- A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion
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, infliximab - within 8 weeks prior to randomisation
- ustekinumab - within 16 weeks prior to randomisation
- other products - within 4 weeks/5 half-lives prior to randomisation (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.
- Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation.
- Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
- Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Previously randomised in this trial or any previously conducted trial of LEO 90100.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 | Experimental | LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) Receives: Drug: LEO 90100 |
| Vehicle | Placebo comparator | Aerosol foam vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success According to IGA
Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4.
The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe
Measured: 4 weeks
Secondary outcomes (2)
m-PASI at Week 4
The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).
m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.
The m-PASI score range from 0 (best) to 64.8 (worst).
Measured: 4 weeks
m-PASI at Week 1
The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).
m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.
The m-PASI score range from 0 (best) to 64.8 (worst).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionNov 2013
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 (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Leonardi, Principal investigator, Central Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866163
- Sponsor's protocol ID
- LP0053-1001
- Status last verified
- Sep 2019
- First submitted
- 28 May 2013
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34397196Iversen 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 32785881Stein Gold L, Villumsen J, Rosen M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam is Effective, Independent of Body Mass Index and the Extent and Severity of Psoriasis. Dermatol Ther (Heidelb). 2016 Dec;6(4):667-673. doi: 10.1007/s13555-016-0147-0. Epub 2016 Oct 6.
PubMed 27714595Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Olesen M, Osterdal ML, Stein Gold L. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015 Dec;14(12):1468-77.
PubMed 26659941
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01866163
- Acronym / sponsor ID
- LP0053-1001
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Posted 9 May 2016
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 trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 | Experimental | Drug: LEO 90100LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
| Vehicle | Placebo comparator | Drug: VehicleAerosol foam vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
- Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
- An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
- A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
- A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion
Key exclusion criteria (14 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 |
| Vehicle | Drug | Vehicle |
Primary outcome
Treatment Success According to IGA
Time frame: 4 weeks
Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe
2 secondary outcomes
m-PASI at Week 4
Time frame: 4 weeks
m-PASI at Week 1
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34397196Veverka 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.
- 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.
- Derived from this study: PubMed 27714595Stein Gold L, Villumsen J, Rosen M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam is Effective, Independent of Body Mass Index and the Extent and Severity of Psoriasis. Dermatol Ther (Heidelb). 2016 Dec;6(4):667-673. doi: 10.1007/s13555-016-0147-0. Epub 2016 Oct 6.
- Derived from this study: PubMed 26659941Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Olesen M, Osterdal ML, Stein Gold L. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015 Dec;14(12):1468-77.
- 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.
Craig Leonardi principal investigator
Central Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LEO 90100 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site 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 5 inclusion and 14 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 10 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 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 May 2016). 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?
Treatment Success According to IGA (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 NCT01866163, which also lists 4 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 10 Mar 2025.