Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602341
• Other study ID #: AN2728-AD-204
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2012
• Last updated: June 21, 2013
• Start date: August 2012

Study information

• Verified date: June 2013
• Source: Anacor Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 2% QD
• AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 0.5% QD
• AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 2% BID
• AN2728 Topical Ointment, 0.5% BID
AN2728 Topical Ointment, 0.5% BID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Anacor Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in ADSI score compared between 0.5% and 2% ointment applied QD or BID for up to 29 days	% of subjects where one concentration or dosing schedule performs better (greater decrease in ADSI score)	Days 8, 15, 22, and 29	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability (systemic and local) of treatment for up to 29 days		Up to 29 days	Yes
Secondary	Differences in ADSI component subscores compared between 0.5% and 2% ointment applied QD or BID for up to 29 days		Up to 29 days	No