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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

AN2728 Cream, 2%

AN2728 Cream, 1%

AN2728 Cream, 0.3%

AN2728 Cream Vehicle

Betnesol®-V Creme, 0.1%

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Plaque Type Psoriasis, Topical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Bioskin GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

AN2728 Cream, 2%

AN2728 Cream, 1%

AN2728 Cream, 0.3%

AN2728 Cream Vehicle

Betnesol®-V Creme (betamethasone 0.1 %)

Outcomes

Primary Outcome Measures

Efficacy of the active study preparations compared to the corresponding vehicle using differences in infiltrate thickness on study day 12.

Secondary Outcome Measures

Change in infiltrate thickness

Sonographic measurements of infiltrate thickness

The AUC of the infiltrate thickness

Clinical assessment scores for assessment of efficacy

Full Information

NCT ID

NCT00763204

First Posted

September 26, 2008

Last Updated

February 26, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00763204

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

February 29, 2008 (Actual)

Primary Completion Date

March 7, 2008 (Actual)

Study Completion Date

March 7, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Plaque Type Psoriasis, Topical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AN2728 Cream, 2%

Arm Title

Arm Type

Experimental

Arm Description

AN2728 Cream, 1%

Arm Title

Arm Type

Experimental

Arm Description

AN2728 Cream, 0.3%

Arm Title

Arm Type

Placebo Comparator

Arm Description

AN2728 Cream Vehicle

Arm Title

Arm Type

Active Comparator

Arm Description

Betnesol®-V Creme (betamethasone 0.1 %)

Intervention Type

Drug

Intervention Name(s)

AN2728 Cream, 2%

Intervention Type

Drug

Intervention Name(s)

AN2728 Cream, 1%

Intervention Type

Drug

Intervention Name(s)

AN2728 Cream, 0.3%

Intervention Type

Drug

Intervention Name(s)

AN2728 Cream Vehicle

Intervention Type

Drug

Intervention Name(s)

Betnesol®-V Creme, 0.1%

Other Intervention Name(s)

betamethasone 0.1%

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Change in infiltrate thickness

Time Frame

Day 8

Title

Sonographic measurements of infiltrate thickness

Time Frame

Day 8, Day 12

Title

The AUC of the infiltrate thickness

Time Frame

Day 8, Day 12

Title

Clinical assessment scores for assessment of efficacy

Time Frame

Day 8, Day 12

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Bioskin GmbH

City

Hamburg

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

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

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