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

NCT01300052 | Completed Phase 2 Results

• 2 other identifiers: AN2728-PSR-204C3291017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 10

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.

Conditions

Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84

  PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.

  Day 84

Secondary Outcomes (6)

• Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70

  Day 14, Day 28, Day 42, Day 56, Day 70

• Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84

  Baseline (Day 1), Day 84

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline (Day 1) up to Day 84

• Number of Treatment-Emergent Adverse Events (TEAEs) by Severity

  Baseline (Day 1) up to Day 84

• Number of Participants With Local Tolerability Symptoms: Burning/Stinging

  Baseline (Day 1) up to Day 84

Study Arms (2)

AN2728 ointment, 2%

EXPERIMENTAL

AN2728 ointment, 2%

Drug: AN2728 ointment, 2%

Ointment Vehicle

PLACEBO COMPARATOR

Ointment Vehicle

Drug: Ointment Vehicle

Interventions

AN2728 ointment, 2% DRUG

AN2728 ointment, 2%, applied twice daily for 12 weeks

AN2728 ointment, 2%

Ointment Vehicle DRUG

Ointment Vehicle, applied twice daily for 12 weeks

Ointment Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

The Savin Center

New Haven, Connecticut, 06511, United States

Location

Dermatology Specialists, PSC

Louisville, Kentucky, 40202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432-3133, United States

Location

Karl G. Heine, MD Dermatology

Henderson, Nevada, 89052, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 21, 2011
• Study Start: January 26, 2011
• Primary Completion: June 6, 2011
• Study Completion: June 6, 2011
• Last Updated: April 17, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-03

Locations

US (10)