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

NCT00763204 | Completed Phase 1

• 3 other identifiers: AN2728-PSR-1032007-006600-37C3291022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Plaque Type Psoriasis; Topical

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 (5)

1

EXPERIMENTAL

AN2728 Cream, 2%

Drug: AN2728 Cream, 2%

2

EXPERIMENTAL

AN2728 Cream, 1%

Drug: AN2728 Cream, 1%

3

EXPERIMENTAL

AN2728 Cream, 0.3%

Drug: AN2728 Cream, 0.3%

4

PLACEBO COMPARATOR

AN2728 Cream Vehicle

Drug: AN2728 Cream Vehicle

5

ACTIVE COMPARATOR

Betnesol®-V Creme (betamethasone 0.1 %)

Drug: Betnesol®-V Creme, 0.1%

Interventions

AN2728 Cream, 2% DRUG

1

AN2728 Cream, 1% DRUG

2

AN2728 Cream, 0.3% DRUG

3

AN2728 Cream Vehicle DRUG

4

Betnesol®-V Creme, 0.1% DRUG

Also known as: betamethasone 0.1%

5

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Bioskin GmbH

Hamburg, 10117, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin 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: February 29, 2008
• Primary Completion: March 7, 2008
• Study Completion: March 7, 2008
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

DE (1)