Psoriasis VulgarisPhase 3NCT02132936

LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

A Phase 3 study testing LEO 90100 aerosol foam and Calcipotriol BDP gel in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 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 aerosol foam and Calcipotriol BDP gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 504 participants
Where: 1 siteFrance
Study dates: Jun 2014to Feb 2015
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

Age 18 years or above
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)
A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Who cannot join

Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
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)

Show all 13Show fewer

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 non-marketed 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.
Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
Ultraviolet B (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
Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding

Trial locations and contacts

1 site in 1 country.

France1 site

Service de Dermatologie, Hôspital Larrey
Toulouse, 31059

Other trials in France

About this study

The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Conditions: Psoriasis Vulgaris
Being tested: LEO 90100 aerosol foam, Aerosol foam vehicle, Calcipotriol BDP gel, Gel vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 90100 aerosol foamDrug
Aerosol foam vehicleDrug
Calcipotriol BDP gelDrug
Gel vehicleDrug

Study groups in NCT02132936
Study group	Role	What they receive
LEO 90100	Experimental	LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks Receives: Drug: LEO 90100 aerosol foam
Aerosol foam vehicle	Placebo comparator	Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks Receives: Drug: Aerosol foam vehicle
Calcipotriol BDP gel	Active comparator	Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks Receives: Drug: Calcipotriol BDP gel
Gel vehicle	Placebo comparator	Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks Receives: Drug: Gel vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Success According to the PGA
To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.
Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA).
'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Measured: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel

Secondary outcomes (4)

Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.
Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.
Measured: Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel
Time to 'Treatment Success' According to PGA.
Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.
'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Measured: From Baseline to Week 12
Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).
Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Measured: Baseline to Week 4
Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).
Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Measured: Baseline to Week 4; Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Feb 2015

First posted7 May 2014 (estimated)
Study startJun 2014
Primary completionFeb 2015
Study completionFeb 2015

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: Single blind
Who is masked: Investigator
Enrolment: 504 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02132936
Sponsor's protocol ID: LP0053-1003
Status last verified: Jul 2016
First submitted: 6 May 2014
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Paul C, Stein Gold L, Cambazard F, Kalb RE, Lowson D, Bang B, Griffiths CE. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):119-126. doi: 10.1111/jdv.13859. Epub 2016 Aug 17.
PubMed 27531752
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 34397196
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
Paul C, Leonardi C, Menter A, Reich K, Gold LS, Warren RB, Moller A, Lebwohl M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study. Am J Clin Dermatol. 2017 Jun;18(3):405-411. doi: 10.1007/s40257-017-0258-0.
PubMed 28236223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis Vulgaris trials

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 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT02132936
Acronym / sponsor ID: LP0053-1003
Conditions: Psoriasis Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 504 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 7 May 2014 (estimated)
Results: Posted 2 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 is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
LEO 90100	Experimental	Drug: LEO 90100 aerosol foamLEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
Aerosol foam vehicle	Placebo comparator	Drug: Aerosol foam vehicleAerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Calcipotriol BDP gel	Active comparator	Drug: Calcipotriol BDP gelCalcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Gel vehicle	Placebo comparator	Drug: Gel vehicleGel vehicle, 60 g per bottle, applied once daily up to 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 years or above
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)
A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Key exclusion criteria (13 listed)

Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
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 non-marketed 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.
Psoralen combined with Ultraviolet A (PUVA) therapy within 4 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 aerosol foam	Drug	LEO 90100
Aerosol foam vehicle	Drug	Aerosol foam vehicle
Calcipotriol BDP gel	Drug	Calcipotriol BDP gel
Gel vehicle	Drug	Gel vehicle

Primary outcome

Treatment Success According to the PGA
Time frame: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel
To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.

4 secondary outcomes

Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.
Time frame: Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel
Time to 'Treatment Success' According to PGA.
Time frame: From Baseline to Week 12
Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).
Time frame: Baseline to Week 4
Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).
Time frame: Baseline to Week 4; Baseline to Week 8

Results and safety

Results posted to the registry on 2 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LEO 90100	185	175
Aerosol Foam Vehicle	47	38
Calcipotriol BDP Gel	188	174
Gel Vehicle	43	29

Primary outcome: Treatment Success According to the PGA

Time frame: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel. Number. Unit: percentage of subjects

Measure	LEO 90100 n = 185	Calcipotriol BDP Gel n = 188
Value	38.3	22.5

LEO 90100 vs Calcipotriol BDP Gel: Odds Ratio (OR): 2.55 (95% CI 1.46 to 4.46), p <0.001, Mantel Haenszel

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 until week 12. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 90100	4 of 185 (2.2%)	62 of 185 (33.5%)	Not reported
Aerosol Foam Vehicle	0 of 47 (0%)	25 of 47 (53.2%)	Not reported
Calcipotriol BDP Gel	3 of 188 (1.6%)	60 of 188 (31.9%)	Not reported
Gel Vehicle	1 of 43 (2.3%)	28 of 43 (65.1%)	Not reported

Limitations and caveats (from the sponsor): None reported

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.
Results publication: PubMed 27531752Paul C, Stein Gold L, Cambazard F, Kalb RE, Lowson D, Bang B, Griffiths CE. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):119-126. doi: 10.1111/jdv.13859. Epub 2016 Aug 17.
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 28236223Paul C, Leonardi C, Menter A, Reich K, Gold LS, Warren RB, Moller A, Lebwohl M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study. Am J Clin Dermatol. 2017 Jun;18(3):405-411. doi: 10.1007/s40257-017-0258-0.
Individual participant dataSharing planned: No

Related trials for Psoriasis Vulgaris

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 aerosol foam and Calcipotriol BDP gel in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.

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 4 inclusion and 13 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 France. 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 2 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 the PGA (time frame: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel). 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 NCT02132936, 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.