AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, 12-Week Study of the Safety and Efficacy of AN2728 Versus AN2728 Vehicle in the Treatment of Patients With Mild-to-Moderate Plaque-Type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300052
• Other study ID #: AN2728-PSR-204
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2011
• Last updated: August 11, 2016
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: August 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals

• Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits

• Women of childbearing potential must agree to use contraception for the entire study period

Exclusion Criteria:

• Any dermatological conditions that could interfere with clinical evaluations

• Concurrent or recent use of certain topical or systemic medications without a sufficient washout period

• Significant confounding conditions as assessed by study doctor

• Participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study

• Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)

• Use of a beta-blocking medication (e.g., propranolol) if the dose has not been stabilized for at least 3 months

• Pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 12 weeks
• Ointment Vehicle
Ointment Vehicle, applied twice daily for 12 weeks

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc	Austin	Texas
United States	J&S Studies, Inc.	College Station	Texas
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Karl G. Heine, MD Dermatology	Henderson	Nevada
United States	Dermatology Consulting Services	High Point	North Carolina
United States	The Center for Skin Research	Houston	Texas
United States	Dermatology Specialists, PSC	Louisville	Kentucky
United States	The Savin Center	New Haven	Connecticut
United States	Oregon Medical Research Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving success in Physician's Global Assessment (PGA) of disease severity, defined as a PGA of 'Clear' or 'Almost Clear', with at least a 2-grade improvement from baseline at Day 84		Day 84	No
Secondary	Proportion of subjects achieving success in PGA at Days 14, 28, 42, 56, and 70		Days 14, 28, 42, 56, and 70	No
Secondary	Difference in the proportion of subjects achieving success in PGA between groups at Days 14, 28, 42, 56, 70, and 84		Days 14, 28, 42, 56, 70, and 84	No
Secondary	Change in Percent Body Surface Area (%BSA) involved with psoriasis (excluding face and scalp) from Baseline to Day 84		Day 84	No
Secondary	Frequency and severity of adverse events in subjects treated for up to 84 days		Up to Day 84	Yes
Secondary	Local tolerability signs/symptoms in subjects treated for up to 84 days		Up to day 84	Yes