Clinical trial NCT01602341: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
timeFrame: Baseline, Day 8
measure: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
timeFrame: Baseline, Day 15
measure: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
timeFrame: Baseline, Day 22
measure: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
timeFrame: Baseline, Day 29
Secondary outcomes:
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
timeFrame: Baseline up to Day 29
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 29
measure: Number of Participants With Treatment-Emergent Adverse Events By Severity
timeFrame: Baseline up to Day 29
measure: Number of Participants With Local Tolerability Symptoms
timeFrame: Baseline up to Day 29
measure: Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
timeFrame: Baseline, Day 8, 15, 22, 29
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Anacor Investigational Site
state: California
city: Miami
country: United States
facility: Anacor Investigational Site
state: Florida
city: Lousiville
country: United States
facility: Anacor Investigational Site
state: Kentucky
city: Detroit
country: United States
facility: Anacor Investigational Site
state: Michigan
city: Albuquerque
country: United States
facility: Anacor Investigational Site
state: New Mexico
city: Stony Brook
country: United States
facility: Anacor Investigational Site
state: New York
city: High Point
country: United States
facility: Anacor Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Anacor Investigational Site
state: Oregon
city: Knoxville
country: United States
facility: Anacor Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Anacor Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Anacor Investigational Site
state: Virginia
city: Phillip
country: Australia
facility: Anacor Investigational Site
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Anacor Investigational Site
state: New South Wales
city: Wooloongabba
country: Australia
facility: Anacor Investigational Site
state: Queensland
city: Box Hill
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Anacor Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: