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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01301508
Registration number
NCT01301508
Ethics application status
Date submitted
17/02/2011
Date registered
23/02/2011
Date last updated
22/02/2019
Titles & IDs
Public title
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
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Scientific title
A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis
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Secondary ID [1]
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C3471001
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Secondary ID [2]
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AN2898-AD-202
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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 ointment, 2%
Treatment: Drugs - AN2898 ointment, 1%
Treatment: Drugs - AN2898 ointment vehicle
Treatment: Drugs - AN2728 ointment vehicle
Experimental: AN2898 ointment, 1%, vs. ointment vehicle - AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
Experimental: AN2728 ointment, 2%, vs. ointment vehicle - AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
Treatment: Drugs: AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 6 weeks
Treatment: Drugs: AN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
Treatment: Drugs: AN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
Treatment: Drugs: AN2728 ointment vehicle
AN2728 ointment vehicle applied twice daily for 6 weeks
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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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Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
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Assessment method [1]
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ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
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Timepoint [1]
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Baseline (Day 1)
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Primary outcome [2]
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Atopic Dermatitis Severity Index (ADSI) Score at Day 14
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Assessment method [2]
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ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
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Timepoint [2]
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Day 14
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Primary outcome [3]
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Atopic Dermatitis Severity Index (ADSI) Score at Day 28
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Assessment method [3]
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ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
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Timepoint [3]
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Day 28
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Primary outcome [4]
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Atopic Dermatitis Severity Index (ADSI) Score at Day 42
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Assessment method [4]
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ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
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Timepoint [4]
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Day 42
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Primary outcome [5]
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Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
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Assessment method [5]
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ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.
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Timepoint [5]
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Baseline (Day 1), Day 28
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Eligibility
Key inclusion criteria
* Clinical diagnosis of atopic dermatitis that has been clinically stable for =1 month
* Total body surface area (BSA) of atopic dermatitis involvement =35%, excluding involvement of the face, scalp, and groin
* Presence of two (2) comparable target lesions
* Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
* Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.
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Minimum age
18
Years
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Maximum age
75
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
* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
* Significant confounding conditions as assessed by study doctor
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation
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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
1/05/2011
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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
11/11/2011
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Sample size
Target
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Accrual to date
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Final
46
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Anacor Investigational Site - Kogarah
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Recruitment hospital [2]
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Anacor Investigational Site - Brisbane
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Recruitment hospital [3]
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Anacor Investigational Site - Woolloongabba
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Recruitment hospital [4]
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Anacor Investigational Site - Adelaide
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Recruitment hospital [5]
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Anacor Investigational Site - Box Hill
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Recruitment hospital [6]
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Anacor Investigational Site - Carlton
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Recruitment hospital [7]
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Anacor Investigational Site - Clayton
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Recruitment hospital [8]
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Anacor Investigational Site - Fitzroy
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Recruitment hospital [9]
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Anacor Investigational Site - Parkville
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Recruitment hospital [10]
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Anacor Investigational Site - Fremantle
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Recruitment hospital [11]
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Anacor Investigational Site - Nedlands
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Recruitment hospital [12]
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Anacor Investigational Site - Subiaco
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Recruitment hospital [13]
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Anacor Investigational Site - Victoria Park
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4000 - Brisbane
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3053 - Carlton
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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3050 - Parkville
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Recruitment postcode(s) [10]
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6160 - Fremantle
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Recruitment postcode(s) [12]
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6008 - Subiaco
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Recruitment postcode(s) [13]
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6100 - Victoria Park
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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 whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
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Trial website
https://clinicaltrials.gov/study/NCT01301508
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Trial related presentations / publications
Murrell DF, Gebauer K, Spelman L, Zane LT. Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study. J Drugs Dermatol. 2015 Oct;14(10):1108-12.
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01301508
Download to PDF