Clinical trial NCT01300052: AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84
timeFrame: Day 84
Secondary outcomes:
measure: Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
timeFrame: Day 14, Day 28, Day 42, Day 56, Day 70
measure: Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84
timeFrame: Baseline (Day 1), Day 84
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Day 84
measure: Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
timeFrame: Baseline (Day 1) up to Day 84
measure: Number of Participants With Local Tolerability Symptoms: Burning/Stinging
timeFrame: Baseline (Day 1) up to Day 84
measure: Number of Participants With Local Tolerability Symptoms: Pruritus
timeFrame: Baseline (Day 1) up to Day 84
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Savin Center
state: Connecticut
city: Louisville
country: United States
facility: Dermatology Specialists, PSC
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Henderson
country: United States
facility: Karl G. Heine, MD Dermatology
state: Nevada
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: