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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Betnesol®-V Creme, 0.1%; Drug: AN2728 Ointment, 5%; Drug: AN2728 Ointment, 2%; Drug: AN2728 Ointment, 0.5%; Drug: AN2728 Ointment Vehicle; Drug: Protopic® Ointment, 0.1 %

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 10117
    • Bioskin GmbH

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; AN2728 Ointment, 5%	Drug: AN2728 Ointment, 5%
EXPERIMENTAL: 2; AN2728 Ointment, 2%	Drug: AN2728 Ointment, 2%
EXPERIMENTAL: 3; AN2728 Ointment, 0.5%	Drug: AN2728 Ointment, 0.5%
PLACEBO_COMPARATOR: 4; AN2728 Ointment Vehicle	Drug: AN2728 Ointment Vehicle
ACTIVE_COMPARATOR: 5; Betnesol®-V Creme (betamethasone 0.1 %)	Drug: Betnesol®-V Creme, 0.1%; Other Names: betamethasone 0.1%
ACTIVE_COMPARATOR: 6; Protopic® Ointment (tacrolimus 0.1 %)	Drug: Protopic® Ointment, 0.1 %; Other Names: tacrolimus 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	Day 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2007
• Primary Completion (ACTUAL): December 7, 2007
• Study Completion (ACTUAL): December 7, 2007

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (ESTIMATE): September 30, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Topical; Plaque Type Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Calcineurin Inhibitors; Betamethasone; Betamethasone sodium phosphate; Tacrolimus
• Other Study ID Numbers: AN2728-PSR-102; 2007-003983-23 (EUDRACT_NUMBER); C3291021 (OTHER: Alias Study Number)