Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
C3471001
Query!
Secondary ID [2]
0
0
AN2898-AD-202
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dermatitis, Atopic
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (Day 1)
Query!
Primary outcome [2]
0
0
Atopic Dermatitis Severity Index (ADSI) Score at Day 14
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Day 14
Query!
Primary outcome [3]
0
0
Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Day 28
Query!
Primary outcome [4]
0
0
Atopic Dermatitis Severity Index (ADSI) Score at Day 42
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Day 42
Query!
Primary outcome [5]
0
0
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline (Day 1), Day 28
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
11/11/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
46
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Anacor Investigational Site - Kogarah
Query!
Recruitment hospital [2]
0
0
Anacor Investigational Site - Brisbane
Query!
Recruitment hospital [3]
0
0
Anacor Investigational Site - Woolloongabba
Query!
Recruitment hospital [4]
0
0
Anacor Investigational Site - Adelaide
Query!
Recruitment hospital [5]
0
0
Anacor Investigational Site - Box Hill
Query!
Recruitment hospital [6]
0
0
Anacor Investigational Site - Carlton
Query!
Recruitment hospital [7]
0
0
Anacor Investigational Site - Clayton
Query!
Recruitment hospital [8]
0
0
Anacor Investigational Site - Fitzroy
Query!
Recruitment hospital [9]
0
0
Anacor Investigational Site - Parkville
Query!
Recruitment hospital [10]
0
0
Anacor Investigational Site - Fremantle
Query!
Recruitment hospital [11]
0
0
Anacor Investigational Site - Nedlands
Query!
Recruitment hospital [12]
0
0
Anacor Investigational Site - Subiaco
Query!
Recruitment hospital [13]
0
0
Anacor Investigational Site - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
4000 - Brisbane
Query!
Recruitment postcode(s) [3]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [6]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [7]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [8]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [9]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [10]
0
0
6160 - Fremantle
Query!
Recruitment postcode(s) [11]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [12]
0
0
6008 - Subiaco
Query!
Recruitment postcode(s) [13]
0
0
6100 - Victoria Park
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01301508
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01301508
Download to PDF