Psoriasis VulgarisPhase 1NCT01105286
A Psoriasis Plaque Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis
A Phase 1 study testing Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues in people with 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 eight different formulations of vitamin D analogues 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
- What is being tested?
- Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jun 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 (ustekinumab) 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 and during the study:
- Potent or very potent (WHO group III-IV) corticosteroids
- PUVA or Grenz ray therapy
Show all 23Show fewer
- Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
- WHO group I-II corticosteroids (except if used for treatment of scalp psoriasis)
- Topical retinoids
- Vitamin D analogues
- Topical immunomodulators (e.g. macrolides)
- Anthracen derivatives
- Tar
- Salicylic acid
- UVB therapy
- Subjects known to be non-responder to topical vitamin D analogues (e.g., known history of no improvement or worsening of psoriasis with e.g., calcipotriol, calcitriol or tacalcitol when used according to current SmPc)
- 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 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
The purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin D analogues using a psoriasis plaque test design
- Conditions
- Psoriasis Vulgaris
- Being tested
- Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analoguesDrug
Once daily application
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriol ointment | Experimental | Not described Receives: Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Clinical Score of clinical symptoms
Measured: 4 weeks
Secondary outcomes (1)
Clinical scores, lesions thickness
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionJun 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
- Single blind
- Who is masked
- 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
- NCT01105286
- Sponsor's protocol ID
- PLQ-005
- Other IDs
- 2009-017393-20, 2009
- Status last verified
- Oct 2013
- First submitted
- 15 Apr 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 Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT01105286
- Acronym / sponsor ID
- PLQ-005
- 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
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Apr 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 eight different formulations of vitamin D analogues using a psoriasis plaque test design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol ointment | Experimental | Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues |
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 (23 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 (ustekinumab) 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 and during the study:
- Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
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 |
|---|---|---|
| Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analoguesOnce daily application | Drug | Calcipotriol ointment |
Primary outcome
Total Clinical Score of clinical symptoms
Time frame: 4 weeks
1 secondary outcome
Clinical scores, lesions thickness
Time frame: 4 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 testing Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues 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 5 inclusion and 23 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: 4 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.