Psoriasis VulgarisPhase 1NCT01946386
A Vasoconstriction Study With LEO 90100
A Phase 1 study testing LEO 90100 Aerosol, foam, Daivobet® ointment and Dermovate® cream in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90100 Aerosol, foam, Daivobet® ointment and Dermovate® cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
- Healthy male or female volunteers, 18 to 50 years old, both inclusive
Who cannot join
- Female subjects who are pregnant or who are breast feeding.
- Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
Trial locations and contacts
1 site in 1 country.
France1 site
CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Nice, 06202
About this study
The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100 Aerosol, foam, Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle, LEO 90100 Aerosol, foam, vehicle, Daivobet® ointment, Dermovate® cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100 Aerosol, foamDrug
The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours
Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicleDrug
LEO 90100 Aerosol, foam, vehicleDrug
Daivobet® ointmentDrug
Dermovate® creamDrug
Synalar® ointmentDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 | Experimental | Not described Receives: Drug: LEO 90100 Aerosol, foam; Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle; Drug: LEO 90100 Aerosol, foam, vehicle; Drug: Daivobet® ointment; Drug: Dermovate® cream; Drug: Synalar® ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of skin blanching (visual score (VS))
Visual Assessment of Skin Blanching on scores 0 to 4
Measured: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Secondary outcomes (2)
Change from baseline in colorimetric parameter a* (the red/green balance) at each time point
Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Measured: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)
AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Measured: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946386
- Sponsor's protocol ID
- LP0053-69
- Status last verified
- Jul 2015
- First submitted
- 11 Sep 2013
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Vasoconstriction Study With LEO 90100
- ClinicalTrials.gov ID
- NCT01946386
- Acronym / sponsor ID
- LP0053-69
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
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 compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 | Experimental | Drug: LEO 90100 Aerosol, foam, Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle, Drug: LEO 90100 Aerosol, foam, vehicle, Drug: Daivobet® ointment, Drug: Dermovate® cream, Drug: Synalar® ointment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
- Healthy male or female volunteers, 18 to 50 years old, both inclusive
Key exclusion criteria (2 listed)
- Female subjects who are pregnant or who are breast feeding.
- Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
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, foamThe products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours | Drug | LEO 90100 |
| Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle | Drug | LEO 90100 |
| LEO 90100 Aerosol, foam, vehicle | Drug | LEO 90100 |
| Daivobet® ointment | Drug | LEO 90100 |
| Dermovate® cream | Drug | LEO 90100 |
| Synalar® ointment | Drug | LEO 90100 |
Primary outcome
Visual assessment of skin blanching (visual score (VS))
Time frame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Visual Assessment of Skin Blanching on scores 0 to 4
2 secondary outcomes
Change from baseline in colorimetric parameter a* (the red/green balance) at each time point
Time frame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)
Time frame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Results publicationQueille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).
- 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.
Medical Expert study director
LEO Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 90100 Aerosol, foam, Daivobet® ointment and Dermovate® cream 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 2 inclusion and 2 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 24 Feb 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual assessment of skin blanching (visual score (VS)) (time frame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application). 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 NCT01946386, which also lists 1 linked publication.
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 24 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.