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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01602341
Registration number
NCT01602341
Ethics application status
Date submitted
17/05/2012
Date registered
21/05/2012
Date last updated
6/03/2017
Titles & IDs
Public title
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
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Scientific 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
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Secondary ID [1]
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AN2728-AD-204
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dermatitis, Atopic
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AN2728 Topical Ointment, 2% QD
Treatment: Drugs - AN2728 Topical Ointment, 0.5% QD
Treatment: Drugs - AN2728 Topical Ointment, 2% BID
Treatment: Drugs - AN2728 Topical Ointment, 0.5% BID
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.
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.
Treatment: Drugs: AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 2% QD
Treatment: Drugs: AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 0.5% QD
Treatment: Drugs: AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 2% BID
Treatment: Drugs: AN2728 Topical Ointment, 0.5% BID
AN2728 Topical Ointment, 0.5% BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Day 8
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Primary outcome [2]
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Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Day 15
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Primary outcome [3]
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Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Day 22
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Primary outcome [4]
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Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Day 29
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Secondary outcome [1]
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Day 29
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Secondary outcome [2]
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to Day 29
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Secondary outcome [3]
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline up to Day 29
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Secondary outcome [4]
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Number of Participants With Treatment-Emergent Adverse Events By Severity
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline up to Day 29
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Secondary outcome [5]
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Number of Participants With Local Tolerability Symptoms
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Assessment method [5]
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Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.
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Timepoint [5]
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Baseline up to Day 29
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Secondary outcome [6]
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Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Day 8, 15, 22, 29
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Eligibility
Key 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
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Minimum age
12
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2013
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Sample size
Target
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Anacor Investigational Site - Phillip
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Recruitment hospital [2]
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Anacor Investigational Site - Kogarah
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Recruitment hospital [3]
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Anacor Investigational Site - Wooloongabba
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Recruitment hospital [4]
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Anacor Investigational Site - Box Hill
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Recruitment hospital [5]
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Anacor Investigational Site - Parkville
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Recruitment hospital [6]
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Anacor Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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- Wooloongabba
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Recruitment postcode(s) [4]
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- Box Hill
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Recruitment postcode(s) [5]
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- Parkville
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Recruitment postcode(s) [6]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Kentucky
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New Mexico
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Oregon
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Country [9]
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United States of America
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State/province [9]
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Tennessee
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Country [10]
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United States of America
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State/province [10]
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Utah
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Country [11]
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United States of America
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State/province [11]
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01602341
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01602341
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