Psoriasis VulgarisPhase 1NCT01043224
A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris
A Phase 1 study of Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects having understood and signed an informed consent form
- Either sex
- Age 18 years or above
- All skin types and any ethnic origin
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk
Who cannot join
- Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
- Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinmab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation
- Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation
- Potent or very potent (WHO group III-IV) corticosteroids
- PUVA or Grenz ray therapy
Show all 24Show fewer
- Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation
- WHO group I-II corticosteroids
- Topical retinoids
- Vitamin D analogues
- Topical immunomodulators (e.g. macrolides)
- Anthracen derivatives
- Tar
- Salicylic acid
- UVB therapy
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
- Subjects with current participation in any other interventional clinical, based on interview of the subject
- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- Subjects with known or suspected hypersensitivity to component(s) of the investigational products
- Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia
- Subjects with known severe hepatic and/or severe renal insufficiency
- Subjects with any of the following conditions present on the plaque test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
- Subjects with skin manifestations on the plaque test areas in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
- Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Psoriasis Plaque Study Comparing Clobetasol Propionate Plus Calcipotriol Ointment With Clobetasol Propionate Ointment Alone, Calcipotriol Ointment Alone and a Vehicle Control for the Treatment of Psoriasis Vulgaris
The purpose of this trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicleDrug
Once daily application
| Study group | Role | What they receive |
|---|---|---|
| Clobetasol propionate plus calcipotriol | Experimental | Not described Receives: Drug: Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Clinical Score of clinical symptoms
Measured: 3 weeks
Secondary outcomes (1)
Clinical scores, lesions thickness, NIR spectroscopic measurements
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Facy, PhD, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043224
- Sponsor's protocol ID
- PLQ-004
- Other IDs
- EudractCT No: 2009-012139-14
- Status last verified
- Oct 2013
- First submitted
- 5 Jan 2010
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psoriasis Plaque Study Comparing Clobetasol Propionate Plus Calcipotriol Ointment With Clobetasol Propionate Ointment Alone, Calcipotriol Ointment Alone and a Vehicle Control for the Treatment of Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01043224
- Acronym / sponsor ID
- PLQ-004
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Jan 2010 (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 trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clobetasol propionate plus calcipotriol | Experimental | Drug: Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects having understood and signed an informed consent form
- Either sex
- Age 18 years or above
- All skin types and any ethnic origin
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk
Key exclusion criteria (24 listed)
- Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
- Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinmab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation
- Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation
- Subjects using one of the following topical drugs for the treatment of psoriasis within 2 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 |
|---|---|---|
| Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicleOnce daily application | Drug | Clobetasol propionate plus calcipotriol |
Primary outcome
Total Clinical Score of clinical symptoms
Time frame: 3 weeks
1 secondary outcome
Clinical scores, lesions thickness, NIR spectroscopic measurements
Time frame: 3 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.
- 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.
Patrice Facy, PhD 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 of 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 5 inclusion and 24 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?
Total Clinical Score of clinical symptoms (time frame: 3 weeks). 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.