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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01300052
First received: February 17, 2011
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: AN2728 ointment, 2%
Drug: Ointment Vehicle
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving success in PGA at Days 14, 28, 42, 56, and 70 [ Time Frame: Days 14, 28, 42, 56, and 70 ] [ Designated as safety issue: No ]
  • Difference in the proportion of subjects achieving success in PGA between groups at Days 14, 28, 42, 56, 70, and 84 [ Time Frame: Days 14, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
  • Change in Percent Body Surface Area (%BSA) involved with psoriasis (excluding face and scalp) from Baseline to Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events in subjects treated for up to 84 days [ Time Frame: Up to Day 84 ] [ Designated as safety issue: Yes ]
  • Local tolerability signs/symptoms in subjects treated for up to 84 days [ Time Frame: Up to day 84 ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2728 ointment, 2%
AN2728 ointment, 2%
Drug: AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 12 weeks
Placebo Comparator: Ointment Vehicle
Ointment Vehicle
Drug: Ointment Vehicle
Ointment Vehicle, applied twice daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300052

Locations
United States, Connecticut
The Savin Center
New Haven, Connecticut, United States, 06511
United States, Kentucky
Dermatology Specialists, PSC
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432-3133
United States, Nevada
Karl G. Heine, MD Dermatology
Henderson, Nevada, United States, 89052
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
J&S Studies, Inc.
College Station, Texas, United States, 77845
The Center for Skin Research
Houston, Texas, United States, 77056
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01300052     History of Changes
Other Study ID Numbers: AN2728-PSR-204
Study First Received: February 17, 2011
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 27, 2014