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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 0.5% BID
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring atopic dermatitis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site
  • Anacor Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AN2728 Topical Ointment, 2% QD vs 0.5% QD

AN2728 Topical Ointment, 2% BID vs 0.5% BID

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 17, 2012
Last Updated
January 12, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01602341
Brief Title
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AN2728 Topical Ointment, 2% QD vs 0.5% QD
Arm Type
Experimental
Arm Description
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.
Arm Title
AN2728 Topical Ointment, 2% BID vs 0.5% BID
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AN2728 Topical Ointment, 2% QD
Intervention Description
AN2728 Topical Ointment, 2% QD
Intervention Type
Drug
Intervention Name(s)
AN2728 Topical Ointment, 0.5% QD
Intervention Description
AN2728 Topical Ointment, 0.5% QD
Intervention Type
Drug
Intervention Name(s)
AN2728 Topical Ointment, 2% BID
Intervention Description
AN2728 Topical Ointment, 2% BID
Intervention Type
Drug
Intervention Name(s)
AN2728 Topical Ointment, 0.5% BID
Intervention Description
AN2728 Topical Ointment, 0.5% BID
Primary Outcome Measure Information:
Title
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
Description
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.
Time Frame
Baseline, Day 8
Title
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
Description
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.
Time Frame
Baseline, Day 15
Title
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
Description
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.
Time Frame
Baseline, Day 22
Title
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
Description
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.
Time Frame
Baseline, Day 29
Secondary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Description
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.
Time Frame
Baseline up to Day 29
Title
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Description
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.
Time Frame
Baseline up to Day 29
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to Day 29
Title
Number of Participants With Treatment-Emergent Adverse Events By Severity
Description
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.
Time Frame
Baseline up to Day 29
Title
Number of Participants With Local Tolerability Symptoms
Description
Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.
Time Frame
Baseline up to Day 29
Title
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
Description
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.
Time Frame
Baseline, Day 8, 15, 22, 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Anacor Investigational Site
City
Fremont
State/Province
California
Country
United States
Facility Name
Anacor Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Anacor Investigational Site
City
Lousiville
State/Province
Kentucky
Country
United States
Facility Name
Anacor Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Anacor Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Anacor Investigational Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Anacor Investigational Site
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Anacor Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Anacor Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Anacor Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Anacor Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Anacor Investigational Site
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Anacor Investigational Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Anacor Investigational Site
City
Wooloongabba
State/Province
Queensland
Country
Australia
Facility Name
Anacor Investigational Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Anacor Investigational Site
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Anacor Investigational Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia

12. IPD Sharing Statement

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

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