Psoriasis VulgarisPhase 1NCT01837576
An Exploratory Psoriasis Plaque Test Study With Different Dose Combinations of Calcipotriol Plus Betamethasone Dipropionate in the Daivobet® Gel Vehicle in Psoriasis Vulgaris
A Phase 1 study testing Calcipotriol plus BDP gel in different doses in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components. 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?
- Calcipotriol plus BDP gel in different doses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide written information.
- Age 18 years or above.
- Males, or females subjects.
- Subjects with lesions of psoriasis vulgaris located on arms and/or legs and/or trunk.
- Subjects with, in the opinion of the investigator, stable psoriasis
- Subjects with psoriasis lesions(plaques)assessed by a Total Clinical Score 4 to 9 inclusive but each individual item ≥ 1.
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- Subjects willing and able to follow all the study procedures and complete the whole study.
- Subjects affiliated to a social security system.
- Female of childbearing potential with a negative urine pregnancy test
Who cannot join
- Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding.
- Systemic treatment with biological therapies within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 halflives (whichever is longer) for experimental biological products prior to randomisation and during the study.
- Systemic treatments with all other therapies than biologicals, (e.g., corticosteroids, retinoids, immunosuppressants) 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 prior to randomisation and during the study: Potent or very potent (WHO group III-IV) corticosteroids (4 weeks).
- Subjects using of phototherapy prior to randomisation and during the study:
- PUVA (4 weeks)
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- UVB (2 weeks).
- 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 fortreatment of scalp and/or facial psoriasis),
- Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. macrolides), Anthracen derivatives, Tar, Salicylic acid
- Subjects using emollients on the selected plaques within one week before randomisation and during the study.
- Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g.,beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomization and during the study.
- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview.
- History of any severe disease or serious current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course
- Subjects who have accepted biopsies with a positive Hepatitis B, Hepatitis C or HIV test
- Subjects who have received treatment with any non marketed drug substance within the 4 week period prior to randomisation or longer, if the class of the substancerequires a longer washout as defined above
- Subjects with current participation in any other interventional clinical
- Subjects with known or suspected hypersensitivity to component(s) of the investigational products.
- Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas.
- Subjects foreseeing an intensive solar exposure during the study or having been exposed within two weeks preceding the screening visit.
- Subjects who have accepted the biopsies with any contraindication to skin biopsy procedures.
- Subjects impossible to contact in case of emergency.
- In the opinion of the investigator, subjects are unlikely to comply with the Clinical Study Protocol.
- Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization.
- Subject under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.
- Subjects previously randomised in this trial.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, Nice Cedex 3, 06202
About this study
The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Calcipotriol plus BDP gel in different doses
- Keywords
- Psoriasis Vulgaris, Calcipotriol, Betamethasone Dipropionate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol plus BDP gel in different dosesDrug
Also called Daivobet gel
Topical , Once daily, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriol plus BDP gel in different doses | Experimental | A-E: calcipotriol, BDP gel in different concentrations Receives: Drug: Calcipotriol plus BDP gel in different doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration)
Measured: 3 weeks
Secondary outcomes (3)
Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.
Measured: 3 weeks
Absolute change in Total Clinical Score (TCS) at individual visits compared to baseline
Measured: 3 weeks
The absolute change in total skin thickness and echopoor band thickness at end of treatment compared to baseline.
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 posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
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
- Not applicable
- 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
- Catherine Queille-Roussel, MD, Principal investigator, Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), 06202 Nice Cedex 3, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837576
- Sponsor's protocol ID
- LP0076-1016
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2013
- 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
- An Exploratory Psoriasis Plaque Test Study With Different Dose Combinations of Calcipotriol Plus Betamethasone Dipropionate in the Daivobet® Gel Vehicle in Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01837576
- Acronym / sponsor ID
- LP0076-1016
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis Vulgaris, Calcipotriol, Betamethasone Dipropionate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Apr 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 evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol plus BDP gel in different doses | Experimental | Drug: Calcipotriol plus BDP gel in different dosesA-E: calcipotriol, BDP gel in different concentrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must provide written information.
- Age 18 years or above.
- Males, or females subjects.
- Subjects with lesions of psoriasis vulgaris located on arms and/or legs and/or trunk.
- Subjects with, in the opinion of the investigator, stable psoriasis
Key exclusion criteria (27 listed)
- Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding.
- Systemic treatment with biological therapies within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 halflives (whichever is longer) for experimental biological products prior to randomisation and during the study.
- Systemic treatments with all other therapies than biologicals, (e.g., corticosteroids, retinoids, immunosuppressants) 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 prior to randomisation and during the study: Potent or very potent (WHO group III-IV) corticosteroids (4 weeks).
- Subjects using of phototherapy 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 |
|---|---|---|
| Calcipotriol plus BDP gel in different dosesAlso: Daivobet gelTopical , Once daily, 3 weeks | Drug | Calcipotriol plus BDP gel in different doses |
Primary outcome
The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration)
Time frame: 3 weeks
3 secondary outcomes
Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.
Time frame: 3 weeks
Absolute change in Total Clinical Score (TCS) at individual visits compared to baseline
Time frame: 3 weeks
The absolute change in total skin thickness and echopoor band thickness at end of treatment compared to baseline.
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.
Catherine Queille-Roussel, MD principal investigator
Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), 06202 Nice Cedex 3, France
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 Calcipotriol plus BDP gel in different doses 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 9 inclusion and 27 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?
The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) (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.