NCT00762658

Brief Summary

To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2007

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

7 days

First QC Date

September 26, 2008

Last Update Submit

February 21, 2019

Conditions

Psoriasis

Keywords

Plaque Type PsoriasisTopical

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12

    Day 12

Secondary Outcomes (4)

  • Change in Infiltrate Thickness

    Day 8

  • Sonographic Measurements of Infiltrate Thickness

    Day 8, Day 12

  • The AUC of the Infiltrate Thickness

    Day 8, Day 12

  • Clinical Assessment Scores for Assessment of Efficacy

    Day 8, Day 12

Study Arms (6)

1

EXPERIMENTAL

AN2728 Ointment, 5%

Drug: AN2728 Ointment, 5%

2

EXPERIMENTAL

AN2728 Ointment, 2%

Drug: AN2728 Ointment, 2%

3

EXPERIMENTAL

AN2728 Ointment, 0.5%

Drug: AN2728 Ointment, 0.5%

4

PLACEBO COMPARATOR

AN2728 Ointment Vehicle

Drug: AN2728 Ointment Vehicle

5

ACTIVE COMPARATOR

Betnesol®-V Creme (betamethasone 0.1 %)

Drug: Betnesol®-V Creme, 0.1%

6

ACTIVE COMPARATOR

Protopic® Ointment (tacrolimus 0.1 %)

Drug: Protopic® Ointment, 0.1 %

Interventions

AN2728 Ointment, 5%DRUG
1
AN2728 Ointment, 2%DRUG
2
AN2728 Ointment, 0.5%DRUG
3
AN2728 Ointment VehicleDRUG
4
Betnesol®-V Creme, 0.1%DRUG
Also known as: betamethasone 0.1%
5
Protopic® Ointment, 0.1 %DRUG
Also known as: tacrolimus 0.1 %
6

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bioskin GmbH

Hamburg, 10117, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

November 30, 2007

Primary Completion

December 7, 2007

Study Completion

December 7, 2007

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

DE(1)