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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01652885
First received: July 20, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Dermatitis, Atopic
Drug: AN2728 Topical Ointment, 2%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN2728 Ointment in Adolescents With Atopic Dermatitis

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

Primary Outcome Measures:
  • Assessment of safety and tolerability [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    Descriptive summarization of safety and tolerability (frequency and severity of systemic and local AEs)


Secondary Outcome Measures:
  • 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) [ Time Frame: Dosing days 2, 4, 6, 9 ] [ Designated as safety issue: No ]
    Cmax, Area Under Curve, Tmax, t1/2

  • Achievement of treatment success [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    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)

  • Improvement in the signs and symptoms of atopic dermatitis [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    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)


Enrollment: 23
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
Drug: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%

  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)
  • 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
  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: NCT01652885

Locations
United States, California
Anacor Investigational Site
Fremont, California, United States, 94538
Anacor Investigational Site
San Diego, California, United States, 92123
United States, Indiana
Anacor Investigational Site
Indianapolis, Indiana, United States, 46256
United States, North Carolina
Anacor Investigational Site
High Point, North Carolina, United States, 27262
Anacor Investigational Site
Winston-Salem, North Carolina, United States, 27104
United States, Texas
Anacor Investigational Site
Houston, Texas, United States, 77030
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: NCT01652885     History of Changes
Other Study ID Numbers: AN2728-AD-203
Study First Received: July 20, 2012
Last Updated: February 12, 2014
Health Authority: 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 September 14, 2014