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A Phase I Study to Assess Novel Cream 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: NCT00763204
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: AN2728 Cream, 2% Drug: AN2728 Cream, 1% Drug: AN2728 Cream, 0.3% Drug: AN2728 Cream Vehicle Drug: Betnesol®-V Creme, 0.1% Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 29, 2008
Actual Primary Completion Date : March 7, 2008
Actual Study Completion Date : March 7, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 1
AN2728 Cream, 2%
Drug: AN2728 Cream, 2%
Experimental: 2
AN2728 Cream, 1%
Drug: AN2728 Cream, 1%
Experimental: 3
AN2728 Cream, 0.3%
Drug: AN2728 Cream, 0.3%
Placebo Comparator: 4
AN2728 Cream Vehicle
Drug: AN2728 Cream Vehicle
Active Comparator: 5
Betnesol®-V Creme (betamethasone 0.1 %)
Drug: Betnesol®-V Creme, 0.1%
Other Name: betamethasone 0.1%

Primary Outcome Measures :
  1. Efficacy of the active study preparations compared to the corresponding vehicle using differences in infiltrate thickness on study day 12. [ Time Frame: Day 12 ]

Secondary Outcome Measures :
  1. Change in infiltrate thickness [ Time Frame: Day 8 ]
  2. Sonographic measurements of infiltrate thickness [ Time Frame: Day 8, Day 12 ]
  3. The AUC of the infiltrate thickness [ Time Frame: Day 8, Day 12 ]
  4. Clinical assessment scores for assessment of efficacy [ Time Frame: Day 8, Day 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763204

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Bioskin GmbH
Hamburg, Germany, 10117
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Pfizer Identifier: NCT00763204    
Other Study ID Numbers: AN2728-PSR-103
2007-006600-37 ( EudraCT Number )
C3291022 ( Other Identifier: Alias Study Number )
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Pfizer:
Plaque Type Psoriasis
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents