Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01301508




Trial ID
NCT01301508
Ethics application status
Date submitted
17/02/2011
Date registered
21/02/2011
Date last updated
12/01/2017

Titles & IDs
Public title
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
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
Secondary ID [1] 0 0
C3471001
Secondary ID [2] 0 0
AN2898-AD-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis, Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) - 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.
Timepoint [1] 0 0
Baseline (Day 1)
Primary outcome [2] 0 0
Atopic Dermatitis Severity Index (ADSI) Score at Day 14 - 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.
Timepoint [2] 0 0
Day 14
Primary outcome [3] 0 0
Atopic Dermatitis Severity Index (ADSI) Score at Day 28 - 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.
Timepoint [3] 0 0
Day 28
Primary outcome [4] 0 0
Atopic Dermatitis Severity Index (ADSI) Score at Day 42 - 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.
Timepoint [4] 0 0
Day 42
Primary outcome [5] 0 0
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 - 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.
Timepoint [5] 0 0
Baseline (Day 1), Day 28

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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Anacor Investigational Site - Kogarah
Recruitment hospital [2] 0 0
Anacor Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Anacor Investigational Site - Woolloongabba
Recruitment hospital [4] 0 0
Anacor Investigational Site - Adelaide
Recruitment hospital [5] 0 0
Anacor Investigational Site - Box Hill
Recruitment hospital [6] 0 0
Anacor Investigational Site - Carlton
Recruitment hospital [7] 0 0
Anacor Investigational Site - Clayton
Recruitment hospital [8] 0 0
Anacor Investigational Site - Fitzroy
Recruitment hospital [9] 0 0
Anacor Investigational Site - Parkville
Recruitment hospital [10] 0 0
Anacor Investigational Site - Fremantle
Recruitment hospital [11] 0 0
Anacor Investigational Site - Nedlands
Recruitment hospital [12] 0 0
Anacor Investigational Site - Subiaco
Recruitment hospital [13] 0 0
Anacor Investigational Site - Victoria Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6008 - Subiaco
Recruitment postcode(s) [13] 0 0
6100 - Victoria Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01301508
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries