Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

An Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN2728 Ointment in Adolescents With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652885
• Other study ID #: AN2728-AD-203
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 20, 2012
• Last updated: February 12, 2014
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2014
• Source: Anacor Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• 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)

• AD in treatable areas (excludes the scalp and venous access areas) involving

=10% and =35% of the total body surface area(BSA)

• Investigator's Static Global Assessment (ISGA) score of 2 or 3

• Normal or not clinically significant screening laboratory results

• Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site

• Willing and able to comply with study instructions and commit to attending all visits

• Females must use a highly effective method of birth control.

• 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 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%

Locations

Country	Name	City	State
United States	Anacor Investigational Site	Fremont	California
United States	Anacor Investigational Site	High Point	North Carolina
United States	Anacor Investigational Site	Houston	Texas
United States	Anacor Investigational Site	Indianapolis	Indiana
United States	Anacor Investigational Site	San Diego	California
United States	Anacor Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Anacor Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety and tolerability	Descriptive summarization of safety and tolerability (frequency and severity of systemic and local AEs)	up to 28 days	Yes
Secondary	Profile of pharmacokinetics on Days 2,4,6,9 at timepoints 0,1,2,4,6,8 hrs post-dose (only timepoint 0 on Day 9)	Cmax, Area Under Curve, Tmax, t1/2	Dosing days 2, 4, 6, 9	No
Secondary	Achievement of treatment success	Achievement of treatment success (defined as a score of Clear or Almost Clear with a 2-grade improvement from Baseline) will be based on the ISGA, a 5-point scale from 0 (clear) to 4 (severe)	up to 28 days	No
Secondary	Improvement in the signs and symptoms of atopic dermatitis	Improvement from Baseline in the signs and symptoms of AD, including erythema, excoriation, exudation, lichenification, and pruritus, will be based on a 4-point scale from 0 (none) to 3 (severe)	up to 28 days	No