A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test
NCT00763204
ABOUT THIS STUDY
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1-800-718-1021
- male subjects aged 18 years or older
- subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for five treatment fields
- the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- written informed consent obtained
- subjects with psoriasis guttata or pustular psoriasis
- subjects who require systemically acting medications for the treatment of psoriasis,
which might counter or influence the study objectives, e.g. corticosteroids,
cytostatics
- local treatment with antipsoriatics (like vitamin D, dithranol, glucocorticosteroids;
except for salicyclic acid in vaseline) in the 4 weeks preceding and during the study;
and any antipsoriatic treatment on the plaques (including corticosteroids, except for
salicyclic acid) in the 8 weeks preceding and during the study.
- systemic treatment with antipsoriatics in the three months preceding and during the
study
- treatment with systemic or locally acting medications which might counter or influence
the study aim (e.g. MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or
medications which are known to provoke or aggravate psoriasis, e.g. Beta-blocker,
antimalarial drugs and lithium drugs within two weeks before the beginning of the
study and during the study.
- known allergic reactions to the active ingredients or other components of the study
preparations or comparators
- blood pressure and heart rate outside the following allowed ranges: systolic blood
pressure 80-160 mm Hg, diastolic blood pressure 60 - 100 mm Hg, heart rate 40-120
beats/min
- evidence of drug abuse
- UV-therapy within 4 weeks before beginning and during the study
- Symptoms of a clinically significant illness that may influenced the outcome of the
study in the 4 weeks before and during the study
- participation in another clinical trial involving pharmaceutical products in the 4
weeks preceding and during the study
- in the opinion of the investigator or physician performing the initial examination the
patient should not participate in the study, e.g. due to probable noncompliance or
inability to understand the study and give adequately informed consent
- subject is institutionalized because of legal or regulatory order
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Descriptive Information | |||||
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Brief Title ICMJE | A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test | ||||
Official Title ICMJE | A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Cream In A Psoriasis Plaque Test | ||||
Brief Summary | The purpose of this study is to investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations with AN2728 in subjects with psoriasis vulgaris. | ||||
Detailed Description | The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparator will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments. Altogether six test fields will be examined per subject (four active AN2728 creams of different concentrations: 2 %, 1 %, 0.3 %, 0.03 %, the active ingredient-free vehicle, and a marketed corticoid preparation). The test fields will be treated occlusively over a study period of 12 days. Topical application of approximately 200 uL of each assigned intervention is administered per treatment, for a total of 10 treatments over a 12-day treatment period. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE | Psoriasis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 12 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 7, 2008 | ||||
Actual Primary Completion Date | March 7, 2008 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00763204 | ||||
Other Study ID Numbers ICMJE | AN2728-PSR-103 2007-006600-37 ( EudraCT Number ) C3291022 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | February 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |