Psoriasis VulgarisPhase 1NCT02973776
Vasoconstriction Trial With LEO 90100 Aerosol Foam
A Phase 1 study testing LEO 90100 aerosol foam, Dermoval®/Dermovate® and Diprosone in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
Vasoconstriction study with LEO 90100 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, Dermoval®/Dermovate® and Diprosone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Feb 2017
- 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
- Subjects demonstrating adequate vasoconstriction to Diprosone® ointment within 15 days prior to dosing (unoccluded application of Diprosone® ointment for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)).
- Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
Who cannot join
- Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the trial results (skin type V and VI on the Fitzpatrick scale).
- Female subjects who are breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle
Vasoconstriction study with LEO 90100
Read the detailed description
This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching test
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100 aerosol foam, Dermoval®/Dermovate®, Diprosone, Elocon, Locoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100 aerosol foamDrug
Dermoval®/Dermovate®Drug
DiprosoneDrug
EloconDrug
LocoidDrug
LEO 90100 foam vehicleOther
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 aerosol foam | Experimental | LEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. Receives: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle |
| Dermoval®/Dermovate® | Active comparator | Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. Receives: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle |
| Diprosone® | Active comparator | Diprosone® betamethasone 0.5 mg/g (as dipropionate) ointment
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. Receives: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle |
| Elocon® | Active comparator | Elocon® mometasone furoate 0.1% cream
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. Receives: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle |
| Locoid® | Active comparator | Locoid® hydrocortisone-17-butyrate 0.1% ointment
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. Receives: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle |
| LEO 90100 foam vehicle | Placebo comparator | LEO 90100 foam vehicle
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. Receives: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973776
- Sponsor's protocol ID
- LP0053-1276
- Status last verified
- May 2017
- First submitted
- 22 Nov 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle
- ClinicalTrials.gov ID
- NCT02973776
- Acronym / sponsor ID
- LP0053-1276
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Nov 2016 (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.
Vasoconstriction study with LEO 90100
Detailed description
This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone ointment, Elocon cream, Locoid 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
- 6
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 aerosol foam | Experimental | Drug: LEO 90100 aerosol foam, Drug: Dermoval®/Dermovate®, Drug: Diprosone, Drug: Elocon, Drug: Locoid, Other: LEO 90100 foam vehicleLEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
| Dermoval®/Dermovate® | Active comparator | Drug: LEO 90100 aerosol foam, Drug: Dermoval®/Dermovate®, Drug: Diprosone, Drug: Elocon, Drug: Locoid, Other: LEO 90100 foam vehicleDermoval®/Dermovate® (clobetasol propionate 0.05%) cream Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
| Diprosone® | Active comparator | Drug: LEO 90100 aerosol foam, Drug: Dermoval®/Dermovate®, Drug: Diprosone, Drug: Elocon, Drug: Locoid, Other: LEO 90100 foam vehicleDiprosone® betamethasone 0.5 mg/g (as dipropionate) ointment Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
| Elocon® | Active comparator | Drug: LEO 90100 aerosol foam, Drug: Dermoval®/Dermovate®, Drug: Diprosone, Drug: Elocon, Drug: Locoid, Other: LEO 90100 foam vehicleElocon® mometasone furoate 0.1% cream Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
| Locoid® | Active comparator | Drug: LEO 90100 aerosol foam, Drug: Dermoval®/Dermovate®, Drug: Diprosone, Drug: Elocon, Drug: Locoid, Other: LEO 90100 foam vehicleLocoid® hydrocortisone-17-butyrate 0.1% ointment Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
| LEO 90100 foam vehicle | Placebo comparator | Drug: LEO 90100 aerosol foam, Drug: Dermoval®/Dermovate®, Drug: Diprosone, Drug: Elocon, Drug: Locoid, Other: LEO 90100 foam vehicleLEO 90100 foam vehicle Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects demonstrating adequate vasoconstriction to Diprosone® ointment within 15 days prior to dosing (unoccluded application of Diprosone® ointment for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)).
- Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
Key exclusion criteria (2 listed)
- Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the trial results (skin type V and VI on the Fitzpatrick scale).
- Female subjects who are breastfeeding.
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 | Dermoval®/Dermovate®, Diprosone®, Elocon®, LEO 90100 aerosol foam, LEO 90100 foam vehicle, Locoid® |
| Dermoval®/Dermovate® | Drug | Dermoval®/Dermovate®, Diprosone®, Elocon®, LEO 90100 aerosol foam, LEO 90100 foam vehicle, Locoid® |
| Diprosone | Drug | Dermoval®/Dermovate®, Diprosone®, Elocon®, LEO 90100 aerosol foam, LEO 90100 foam vehicle, Locoid® |
| Elocon | Drug | Dermoval®/Dermovate®, Diprosone®, Elocon®, LEO 90100 aerosol foam, LEO 90100 foam vehicle, Locoid® |
| Locoid | Drug | Dermoval®/Dermovate®, Diprosone®, Elocon®, LEO 90100 aerosol foam, LEO 90100 foam vehicle, Locoid® |
| LEO 90100 foam vehicle | Other | Dermoval®/Dermovate®, Diprosone®, Elocon®, LEO 90100 aerosol foam, LEO 90100 foam vehicle, Locoid® |
Primary outcome
Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions
Time frame: 18 hours
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 9 May 2017.
- Individual participant dataSharing planned: No
Related trials for Psoriasis Vulgaris
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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 1 study testing LEO 90100 aerosol foam, Dermoval®/Dermovate® and Diprosone 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 9 May 2017. 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 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?
Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.