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

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

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)

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: AN2728 Topical Ointment, 2% QD; Drug: AN2728 Topical Ointment, 0.5% QD; Drug: AN2728 Topical Ointment, 2% BID; Drug: AN2728 Topical Ointment, 0.5% BID

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Anacor Investigational Site
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Anacor Investigational Site
  • Queensland
    • Wooloongabba, Queensland, Australia
      • Anacor Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia
      • Anacor Investigational Site
    • Parkville, Victoria, Australia
      • Anacor Investigational Site
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Anacor Investigational Site
• United States
  • California
    • Fremont, California, United States
      • Anacor Investigational Site
  • Florida
    • Miami, Florida, United States
      • Anacor Investigational Site
  • Kentucky
    • Lousiville, Kentucky, United States
      • Anacor Investigational Site
  • Michigan
    • Detroit, Michigan, United States
      • Anacor Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Anacor Investigational Site
  • New York
    • Stony Brook, New York, United States
      • Anacor Investigational Site
  • North Carolina
    • High Point, North Carolina, United States
      • Anacor Investigational Site
  • Oregon
    • Portland, Oregon, United States
      • Anacor Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States
      • Anacor Investigational Site
  • Utah
    • Salt Lake City, Utah, United States
      • Anacor Investigational Site
  • Virginia
    • Norfolk, Virginia, United States
      • Anacor Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AN2728 Topical Ointment, 2% QD vs 0.5% QD; AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion Treatments will be randomly assigned to target lesions A and B.	Drug: AN2728 Topical Ointment, 2% QD; AN2728 Topical Ointment, 2% QD; Drug: AN2728 Topical Ointment, 0.5% QD; AN2728 Topical Ointment, 0.5% QD
Experimental: AN2728 Topical Ointment, 2% BID vs 0.5% BID; AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion. Treatments will be randomly assigned to target lesions A and B.	Drug: AN2728 Topical Ointment, 2% BID; AN2728 Topical Ointment, 2% BID; Drug: AN2728 Topical Ointment, 0.5% BID; AN2728 Topical Ointment, 0.5% BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.	Baseline, Day 8
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.	Baseline, Day 15
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.	Baseline, Day 22
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.	Baseline, Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.	Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities	Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.	Baseline up to Day 29
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.	Baseline up to Day 29
Number of Participants With Treatment-Emergent Adverse Events By Severity	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.	Baseline up to Day 29
Number of Participants With Local Tolerability Symptoms	Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.	Baseline up to Day 29
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.	Baseline, Day 8, 15, 22, 29

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (Estimate): May 21, 2012

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AN2728-AD-204