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

February 26, 2019 updated by: Pfizer

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hamburg, Germany, 10117
        • Bioskin GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AN2728 Cream, 2%
Experimental: 2
AN2728 Cream, 1%
Experimental: 3
AN2728 Cream, 0.3%
Placebo Comparator: 4
AN2728 Cream Vehicle
Active Comparator: 5
Betnesol®-V Creme (betamethasone 0.1 %)
Other Names:
  • betamethasone 0.1%

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in infiltrate thickness
Time Frame: Day 8
Day 8
Sonographic measurements of infiltrate thickness
Time Frame: Day 8, Day 12
Day 8, Day 12
The AUC of the infiltrate thickness
Time Frame: Day 8, Day 12
Day 8, Day 12
Clinical assessment scores for assessment of efficacy
Time Frame: Day 8, Day 12
Day 8, Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2008

Primary Completion (Actual)

March 7, 2008

Study Completion (Actual)

March 7, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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