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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


Phase 2
12 Years
17 Years
Not Enrolling
Both
Dermatitis, Atopic

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change from Baseline in ADSI score compared between 0.5% and 2% ointment applied QD or BID for up to 29 days

Outcome Description:

% of subjects where one concentration or dosing schedule performs better (greater decrease in ADSI score)

Outcome Time Frame:

Days 8, 15, 22, and 29

Safety Issue:

No

Principal Investigator

Lee Zane, MD, MS, MAS

Investigator Role:

Study Director

Investigator Affiliation:

Anacor Pharmaceuticals, Inc.

Authority:

Australia: Human Research Ethics Committee

Study ID:

AN2728-AD-204

NCT ID:

NCT01602341

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Dermatitis, Atopic
  • atopic dermatitis
  • Dermatitis
  • Dermatitis, Atopic

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