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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762658
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : February 22, 2019
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE November 30, 2007
Actual Primary Completion Date December 7, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12 [ Time Frame: Day 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
  • Change in Infiltrate Thickness [ Time Frame: Day 8 ]
  • Sonographic Measurements of Infiltrate Thickness [ Time Frame: Day 8, Day 12 ]
  • The AUC of the Infiltrate Thickness [ Time Frame: Day 8, Day 12 ]
  • Clinical Assessment Scores for Assessment of Efficacy [ Time Frame: Day 8, Day 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Phase I Study to Assess Novel Ointment 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 Ointment In A Psoriasis Plaque Test
Brief Summary To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris
Detailed Description

The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators 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 (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be 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 Ointment, 5%
  • Drug: AN2728 Ointment, 2%
  • Drug: AN2728 Ointment, 0.5%
  • Drug: AN2728 Ointment Vehicle
  • Drug: Betnesol®-V Creme, 0.1%
    Other Name: betamethasone 0.1%
  • Drug: Protopic® Ointment, 0.1 %
    Other Name: tacrolimus 0.1 %
Study Arms  ICMJE
  • Experimental: 1
    AN2728 Ointment, 5%
    Intervention: Drug: AN2728 Ointment, 5%
  • Experimental: 2
    AN2728 Ointment, 2%
    Intervention: Drug: AN2728 Ointment, 2%
  • Experimental: 3
    AN2728 Ointment, 0.5%
    Intervention: Drug: AN2728 Ointment, 0.5%
  • Placebo Comparator: 4
    AN2728 Ointment Vehicle
    Intervention: Drug: AN2728 Ointment Vehicle
  • Active Comparator: 5
    Betnesol®-V Creme (betamethasone 0.1 %)
    Intervention: Drug: Betnesol®-V Creme, 0.1%
  • Active Comparator: 6
    Protopic® Ointment (tacrolimus 0.1 %)
    Intervention: Drug: Protopic® Ointment, 0.1 %
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 7, 2007
Actual Primary Completion Date December 7, 2007   (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 six 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 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 (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
  • 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. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. β-blocker, antimalarial 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;
  • evidence of drug abuse;
  • UV-therapy within four weeks before beginning and during the study;
  • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
  • participation in another clinical trial involving pharmaceutical products in the four 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 NCT00762658
Other Study ID Numbers  ICMJE AN2728-PSR-102
2007-003983-23 ( EudraCT Number )
C3291021 ( 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 Call Center Pfizer
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