- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043224
A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris
October 24, 2013 updated by: LEO Pharma
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.
Study Overview
Status
Completed
Conditions
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
-
-
-
Nice, France, 06202
- LEO Pharma site
-
-
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 (in summary):
- 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
Exclusion Criteria (in summary):
- 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
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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clobetasol propionate plus calcipotriol
|
Once daily application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Clinical Score of clinical symptoms
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical scores, lesions thickness, NIR spectroscopic measurements
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2010
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
January 5, 2010
First Submitted That Met QC Criteria
January 5, 2010
First Posted (Estimate)
January 6, 2010
Study Record Updates
Last Update Posted (Estimate)
October 25, 2013
Last Update Submitted That Met QC Criteria
October 24, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLQ-004
- EudractCT No: 2009-012139-14 (Registry Identifier: European Clinical Trials Database)
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.
Clinical Trials on Psoriasis Vulgaris
-
LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
-
SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
-
LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
-
PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
University Hospital, GhentBelgium Health Care Knowledge CentreNot yet recruiting
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
-
Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRecruiting
Clinical Trials on Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle
-
First Hospital of China Medical UniversityCompleted
-
BayerTerminated
-
Oslo University HospitalPhotocureCompletedGenital Lichen PlanusNorway
-
Galderma R&DCompletedPlaque PsoriasisUnited States
-
LEO PharmaCompleted
-
Medstar Health Research InstituteCompletedVulvar Lichen SclerosusUnited States
-
LEO PharmaCompleted
-
Mahidol UniversityCompleted
-
Padagis LLCCompleted
-
Medstar Health Research InstitutePatty Brisben Foundation For Women's Sexual Health; Society of Gynecologic...RecruitingFractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus (VULVIE)Vulvar Lichen SclerosusUnited States