Back to resultsA Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
AN2728 Ointment, 5%
AN2728 Ointment, 2%
AN2728 Ointment, 0.5%
AN2728 Ointment Vehicle
Betnesol®-V Creme, 0.1%
Protopic® Ointment, 0.1 %
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Plaque Type Psoriasis, Topical
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 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.
Sites / Locations
- Bioskin GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
5
6
Arm Description
AN2728 Ointment, 5%
AN2728 Ointment, 2%
AN2728 Ointment, 0.5%
AN2728 Ointment Vehicle
Betnesol®-V Creme (betamethasone 0.1 %)
Protopic® Ointment (tacrolimus 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
1. Study Identification
Unique Protocol Identification Number
NCT00762658
Brief Title
A Phase I Study to Assess Novel Ointment 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 Ointment In A Psoriasis Plaque Test
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2007 (Actual)
Primary Completion Date
December 7, 2007 (Actual)
Study Completion Date
December 7, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
1
Arm Type
Experimental
Arm Description
AN2728 Ointment, 5%
Arm Title
2
Arm Type
Experimental
Arm Description
AN2728 Ointment, 2%
Arm Title
3
Arm Type
Experimental
Arm Description
AN2728 Ointment, 0.5%
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
AN2728 Ointment Vehicle
Arm Title
5
Arm Type
Active Comparator
Arm Description
Betnesol®-V Creme (betamethasone 0.1 %)
Arm Title
6
Arm Type
Active Comparator
Arm Description
Protopic® Ointment (tacrolimus 0.1 %)
Intervention Type
Drug
Intervention Name(s)
AN2728 Ointment, 5%
Intervention Type
Drug
Intervention Name(s)
AN2728 Ointment, 2%
Intervention Type
Drug
Intervention Name(s)
AN2728 Ointment, 0.5%
Intervention Type
Drug
Intervention Name(s)
AN2728 Ointment Vehicle
Intervention Type
Drug
Intervention Name(s)
Betnesol®-V Creme, 0.1%
Other Intervention Name(s)
betamethasone 0.1%
Intervention Type
Drug
Intervention Name(s)
Protopic® Ointment, 0.1 %
Other Intervention Name(s)
tacrolimus 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
No
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 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.
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
Learn more about this trial
A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test
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