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

NCT ID: NCT01652885

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-11-30

Brief 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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AN2728 Topical Ointment, 2%

AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days

Group Type: EXPERIMENTAL

AN2728 Topical Ointment, 2%

Intervention Type: DRUG

AN2728 Topical Ointment, 2%

Interventions

AN2728 Topical Ointment, 2%

AN2728 Topical Ointment, 2%

Intervention Type: DRUG

Eligibility 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)
• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Anacor Investigational Site

Fremont, California, United States

Anacor Investigational Site

San Diego, California, United States

Anacor Investigational Site

Indianapolis, Indiana, United States

Anacor Investigational Site

High Point, North Carolina, United States

Anacor Investigational Site

Winston-Salem, North Carolina, United States

Anacor Investigational Site

Houston, Texas, United States

Countries

United States

Other Identifiers

A3191007

Identifier Type: OTHER

Identifier Source: secondary_id

AN2728-AD-203

Identifier Type: -

Identifier Source: org_study_id