Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis - Full Text View

Purpose

The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)

Condition	Intervention	Phase
Dermatitis, Atopic	Drug: AN2728 Topical Ointment, 2% QD Drug: AN2728 Topical Ointment, 0.5% QD Drug: AN2728 Topical Ointment, 2% BID Drug: AN2728 Topical Ointment, 0.5% BID	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis

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

Primary Outcome Measures:

Change from Baseline in ADSI score compared between 0.5% and 2% ointment applied QD or BID for up to 29 days [ Time Frame: Days 8, 15, 22, and 29 ] [ Designated as safety issue: No ]
% of subjects where one concentration or dosing schedule performs better (greater decrease in ADSI score)

Secondary Outcome Measures:

Number of participants with adverse events as a measure of safety and tolerability (systemic and local) of treatment for up to 29 days [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]
Differences in ADSI component subscores compared between 0.5% and 2% ointment applied QD or BID for up to 29 days [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]

Enrollment:	86
Study Start Date:	August 2012
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AN2728 Topical Ointment, 2% QD vs 0.5% QD AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion Treatments will be randomly assigned to target lesions A and B.	Drug: AN2728 Topical Ointment, 2% QD AN2728 Topical Ointment, 2% QD Drug: AN2728 Topical Ointment, 0.5% QD AN2728 Topical Ointment, 0.5% QD
Experimental: AN2728 Topical Ointment, 2% BID vs 0.5% BID AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion. Treatments will be randomly assigned to target lesions A and B.	Drug: AN2728 Topical Ointment, 2% BID AN2728 Topical Ointment, 2% BID Drug: AN2728 Topical Ointment, 0.5% BID AN2728 Topical Ointment, 0.5% BID

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 12 to 17 years of age, inclusive
Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
Total body surface area (BSA) of atopic dermatitis involvement ≤35%
Presence of two comparable target lesions
Willing and able to comply with study instructions and commit to attending all visits
Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion Criteria:

Significant confounding conditions as assessed by study doctor
Unstable or actively infected AD
Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
Current pregnancy or lactation, or intent to become pregnant during the study
Known sensitivity to any of the components of the study drug
Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
Participated in a previous AN2728 clinical study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602341

Locations

United States, California
Anacor Investigational Site
Fremont, California, United States
United States, Florida
Anacor Investigational Site
Miami, Florida, United States
United States, Kentucky
Anacor Investigational Site
Lousiville, Kentucky, United States
United States, Michigan
Anacor Investigational Site
Detroit, Michigan, United States
United States, New Mexico
Anacor Investigational Site
Albuquerque, New Mexico, United States
United States, New York
Anacor Investigational Site
Stony Brook, New York, United States
United States, North Carolina
Anacor Investigational Site
High Point, North Carolina, United States
United States, Oregon
Anacor Investigational Site
Portland, Oregon, United States
United States, Tennessee
Anacor Investigational Site
Knoxville, Tennessee, United States
United States, Utah
Anacor Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
Anacor Investigational Site
Norfolk, Virginia, United States
Australia, Australian Capital Territory
Anacor Investigational Site
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Anacor Investigational Site
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Anacor Investigational Site
Wooloongabba, Queensland, Australia
Australia, Victoria
Anacor Investigational Site
Box Hill, Victoria, Australia
Anacor Investigational Site
Parkville, Victoria, Australia
Australia, Western Australia
Anacor Investigational Site
Fremantle, Western Australia, Australia, 6160

Sponsors and Collaborators

Anacor Pharmaceuticals, Inc.

Investigators

Study Director:

Lee Zane, MD, MS, MAS

Anacor Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01602341 History of Changes
Other Study ID Numbers:	AN2728-AD-204
Study First Received:	May 17, 2012
Last Updated:	January 8, 2013
Health Authority:	Australia: Human Research Ethics Committee Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:

atopic dermatitis

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013