Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01301508
First received: February 17, 2011
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).


Condition Intervention Phase
Dermatitis, Atopic
Drug: AN2728 ointment, 2%
Drug: AN2898 ointment, 1%
Drug: AN2898 ointment vehicle
Drug: AN2728 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 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis

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

Primary Outcome Measures:
  • AD lesions treated with AN2898 ointment or AN2728 ointment will have a greater decrease from Baseline in Atopic Dermatitis Severity Index (ADSI) score on Day 28 compared to lesions treated with the corresponding ointment vehicle [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    % of subjects where test article performs better (greater decrease in ADSI score) than vehicle


Secondary Outcome Measures:
  • AD lesions treated with AN2898 ointment or AN2728 ointment will have a greater decrease from Baseline measures compared to corresponding ointment vehicle [ Time Frame: Days 14, 28, and 42 ] [ Designated as safety issue: No ]
    Statistical and descriptive comparisons of % of subjects where test article performs better (decrease in ADSI & component scores, clearance) than vehicle at indicated timepoints

  • Number of participants with adverse events as a measure of safety and tolerability (systemic and local) of treatment for up to 42 days [ Time Frame: Up to 42 days ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: May 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2898 ointment, 1%, vs. ointment vehicle

AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

Treatments will be randomly assigned to target lesions A and B.

Drug: AN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
Drug: AN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
Experimental: AN2728 ointment, 2%, vs. ointment vehicle

AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

Treatments will be randomly assigned to target lesions A and B.

Drug: AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 6 weeks
Drug: AN2728 ointment vehicle
AN2728 ointment vehicle applied twice daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
  • Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
  • Presence of two (2) comparable target lesions
  • Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
  • Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria:

  • Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
  • Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
  • Significant confounding conditions as assessed by study doctor
  • History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • 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: NCT01301508

Locations
Australia, New South Wales
Anacor Investigational Site
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Anacor Investigational Site
Brisbane, Queensland, Australia, 4000
Anacor Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Anacor Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Anacor Investigational Site
Box Hill, Victoria, Australia, 3128
Anacor Investigational Site
Carlton, Victoria, Australia, 3053
Anacor Investigational Site
Clayton, Victoria, Australia, 3168
Anacor Investigational Site
Fitzroy, Victoria, Australia, 3065
Anacor Investigational Site
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Anacor Investigational Site
Fremantle, Western Australia, Australia, 6160
Anacor Investigational Site
Nedlands, Western Australia, Australia, 6009
Anacor Investigational Site
Subiaco, Western Australia, Australia, 6008
Anacor Investigational Site
Victoria Park, Western Australia, Australia, 6100
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: NCT01301508     History of Changes
Other Study ID Numbers: AN2898-AD-202
Study First Received: February 17, 2011
Last Updated: April 30, 2012
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 20, 2014