A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test

NCT00763204

Last updated date
Study Location
Bioskin GmbH
Hamburg, , 10117, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: AN2728 Cream, 2%
  • Drug: AN2728 Cream, 1%
  • Drug: AN2728 Cream, 0.3%
  • Drug: AN2728 Cream Vehicle
  • Drug: Betnesol®-V Creme, 0.1%
    Other Name: betamethasone 0.1%
Study Arms  ICMJE
  • Experimental: 1
    AN2728 Cream, 2%
    Intervention: Drug: AN2728 Cream, 2%
  • Experimental: 2
    AN2728 Cream, 1%
    Intervention: Drug: AN2728 Cream, 1%
  • Experimental: 3
    AN2728 Cream, 0.3%
    Intervention: Drug: AN2728 Cream, 0.3%
  • Placebo Comparator: 4
    AN2728 Cream Vehicle
    Intervention: Drug: AN2728 Cream Vehicle
  • Active Comparator: 5
    Betnesol®-V Creme (betamethasone 0.1 %)
    Intervention: Drug: Betnesol®-V Creme, 0.1%
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
 (submitted: September 26, 2008)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
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
Study Director:Pfizer CT.gov Call CenterPfizer
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