Psoriasis VulgarisPhase 1NCT01935869
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
A Phase 1 study testing LEO 90100 and Petrolatum ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90100 and Petrolatum ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
- 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.
Who cannot join
- 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
- 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other 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, Hôpital de l'Archet 2
Nice, 06202
About this study
The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100, Vehicle, Petrolatum ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100Drug
VehicleDrug
Petrolatum ointmentDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 | Experimental | Not described Receives: Drug: LEO 90100 |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
| Petrolatum ointment | Other | Not described Receives: Drug: Petrolatum ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cumulative Irritation index and maximal dermal response during induction phase
Measured: 3 weeks
Number of subjects with positive sensitisation reaction at each test site in the challenge phase
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionDec 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 224 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
- NCT01935869
- Sponsor's protocol ID
- LP0053-66
- Status last verified
- Jul 2015
- First submitted
- 27 Aug 2013
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Queille-Roussel C, Liljedahl M, Clonier F, Lacour JP. Phase I evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol. 2015:72 Suppl 1;AB211 (P844).
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
- Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
- ClinicalTrials.gov ID
- NCT01935869
- Acronym / sponsor ID
- LP0053-66
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 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 determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 | Experimental | Drug: LEO 90100 |
| Vehicle | Placebo comparator | Drug: Vehicle |
| Petrolatum ointment | Other | Drug: Petrolatum ointment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
- 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.
Key exclusion criteria (2 listed)
- 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
- 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other 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 | Drug | LEO 90100 |
| Vehicle | Drug | Vehicle |
| Petrolatum ointment | Drug | Petrolatum ointment |
Primary outcome
Mean Cumulative Irritation index and maximal dermal response during induction phase
Time frame: 3 weeks
Number of subjects with positive sensitisation reaction at each test site in the challenge phase
Time frame: 6 weeks
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, Liljedahl M, Clonier F, Lacour JP. Phase I evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol. 2015:72 Suppl 1;AB211 (P844).
- 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 and Petrolatum ointment 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. 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 Cumulative Irritation index and maximal dermal response during induction phase (time frame: 3 weeks). 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?
On the ClinicalTrials.gov record for NCT01935869, 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.