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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
AN2728-AD-204
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 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
Timepoint [1] 0 0
Baseline, Day 8
Primary outcome [2] 0 0
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
Timepoint [2] 0 0
Baseline, Day 15
Primary outcome [3] 0 0
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
Timepoint [3] 0 0
Baseline, Day 22
Primary outcome [4] 0 0
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
Timepoint [4] 0 0
Baseline, Day 29
Secondary outcome [1] 0 0
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Timepoint [1] 0 0
Baseline up to Day 29
Secondary outcome [2] 0 0
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Timepoint [2] 0 0
Baseline up to Day 29
Secondary outcome [3] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Baseline up to Day 29
Secondary outcome [4] 0 0
Number of Participants With Treatment-Emergent Adverse Events By Severity
Timepoint [4] 0 0
Baseline up to Day 29
Secondary outcome [5] 0 0
Number of Participants With Local Tolerability Symptoms
Timepoint [5] 0 0
Baseline up to Day 29
Secondary outcome [6] 0 0
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
Timepoint [6] 0 0
Baseline, Day 8, 15, 22, 29

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
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Anacor Investigational Site - Phillip
Recruitment hospital [2] 0 0
Anacor Investigational Site - Kogarah
Recruitment hospital [3] 0 0
Anacor Investigational Site - Wooloongabba
Recruitment hospital [4] 0 0
Anacor Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Anacor Investigational Site - Parkville
Recruitment hospital [6] 0 0
Anacor Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
- Wooloongabba
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT01602341