Psoriasis VulgarisPhase 1NCT03442244
Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
A Phase 1 study testing LEO 90100 foam in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Japan.
Trial summary
This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90100 foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 30 Jan 2018to 20 Feb 2018
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent has been obtained.
- Healthy Japanese male subjects.
- Aged 20 to 40 years inclusive.
Who cannot join
- Body Mass Index outside the range 18-25 kg/m²
- Use of any medication (systemic or topical) within 2 weeks of Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Irritation Trial of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100 foam, Vehicle of LEO 90100 foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100 foamDrug
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
Vehicle of LEO 90100 foamDrug
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 foam | Experimental | Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g Receives: Drug: LEO 90100 foam |
| Vehicle foam | Placebo comparator | Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner.
Foam vehicle does not contain active ingredients Receives: Drug: Vehicle of LEO 90100 foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin irritation
Skin irritation measured as skin irritation index (summation of clinical scores [ranging from no reaction to blisters] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments
Measured: Up to Day 4
Photo irritation
Positive ratios calculated from the photo irritation scores
Measured: Up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start30 Jan 2018
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442244
- Sponsor's protocol ID
- LP0053-1007
- Status last verified
- Dec 2019
- First submitted
- 29 Jan 2018
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Skin Irritation Trial of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03442244
- Acronym / sponsor ID
- LP0053-1007
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 foam | Experimental | Drug: LEO 90100 foamEach subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g |
| Vehicle foam | Placebo comparator | Drug: Vehicle of LEO 90100 foamEach subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner. Foam vehicle does not contain active ingredients |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed informed consent has been obtained.
- Healthy Japanese male subjects.
- Aged 20 to 40 years inclusive.
Key exclusion criteria (2 listed)
- Body Mass Index outside the range 18-25 kg/m²
- Use of any medication (systemic or topical) within 2 weeks of Day 1.
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 foamEach subject has each of the 2 treatments applied at the same time on 2 different sites on the back | Drug | LEO 90100 foam |
| Vehicle of LEO 90100 foamEach subject has each of the 2 treatments applied at the same time on 2 different sites on the back | Drug | Vehicle foam |
Primary outcome
Skin irritation
Time frame: Up to Day 4
Skin irritation measured as skin irritation index (summation of clinical scores [ranging from no reaction to blisters] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments
Photo irritation
Time frame: Up to Day 4
Positive ratios calculated from the photo irritation scores
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.
- 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.
Study Director 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 foam in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Japan.
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 3 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 Japan. 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?
Skin irritation (time frame: Up to Day 4). The study lists 2 primary outcomes in all. 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 24 Feb 2025.