- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01837576
An Exploratory Psoriasis Plaque Test Study With Different Dose Combinations of Calcipotriol Plus Betamethasone Dipropionate in the Daivobet® Gel Vehicle in Psoriasis Vulgaris
July 22, 2013 updated by: LEO Pharma
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nice Cedex 3
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Nice, Nice Cedex 3, France, 06202
- Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Calcipotriol plus BDP gel in different doses
A-E: calcipotriol, BDP gel in different concentrations
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Topical , Once daily, 3 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration)
Time Frame: 3 weeks
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.
Time Frame: 3 weeks
|
3 weeks
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Absolute change in Total Clinical Score (TCS) at individual visits compared to baseline
Time Frame: 3 weeks
|
3 weeks
|
The absolute change in total skin thickness and echopoor band thickness at end of treatment compared to baseline.
Time Frame: 3 weeks
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3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine Queille-Roussel, MD, Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), 06202 Nice Cedex 3, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
April 22, 2013
First Posted (Estimate)
April 23, 2013
Study Record Updates
Last Update Posted (Estimate)
July 23, 2013
Last Update Submitted That Met QC Criteria
July 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0076-1016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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