Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis

Back to Search
Print
Bookmark Trial

NCT02118792

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Anacor Investigational Site
Henrico, Virginia, , United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females 2 years and older

- Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka

- Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)

- Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1

- All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- As determined by the study doctor, a medical history that may interfere with study
objectives


- Unstable AD or any consistent requirement for high potency topical corticosteroids


- History of use of biologic therapy (including intravenous immunoglobulin)


- Recent or anticipated concomitant use of systemic or topical therapies that might
alter the course of AD


- Recent or current participation in another research study


- Females who are breastfeeding, pregnant, or with plans to get pregnant during the
participation in the study


- Participation in a previous AN2728 clinical trial

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Atopic DermatitisStudy to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis
NCT04668066
  1. Anaheim, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Atopic DermatitisAbrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
NCT04564755
  1. Birmingham, Alabama
  2. Lancaster, California
  3. Long Beach, California
  4. San Diego, California
  5. Farmington, Connecticut
  6. Delray Beach, Florida
  7. Hollywood, Florida
  8. Miami, Florida
  9. Sarasota, Florida
  10. Sunrise, Florida
  11. West Dundee, Illinois
  12. Evansville, Indiana
  13. Evansville, Indiana
  14. Lexington, Kentucky
  15. Ypsilanti, Michigan
  16. Bexley, Ohio
  17. Norman, Oklahoma
  18. Rapid City, South Dakota
  19. Memphis, Tennessee
  20. Houston, Texas
  21. Morgantown, West Virginia
  22. Calgary, Alberta
  23. Markham, Ontario
  24. Peterborough, Ontario
  25. Quebec,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Atopic DermatitisWearable Skin Sensors to Assess Nocturnal Scratch Behavior
NCT03770858
  1. Chicago, Illinois
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Atopic DermatitisImprovement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination of Crisaborole and a Concomitant Topical Corticosteroid Over a 8 Week Period
NCT04008784
  1. Charleston, South Carolina
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
Brief Summary The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: AN2728 Topical Ointment, 2%
  • Drug: Matching vehicle control
Study Arms  ICMJE
  • Experimental: AN2728 Topical Ointment, 2%
    AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
    Intervention: Drug: AN2728 Topical Ointment, 2%
  • Placebo Comparator: Matching vehicle control
    Matching vehicle control, applied twice daily for up to 28 days
    Intervention: Drug: Matching vehicle control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2015)		764
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2014)		750
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females 2 years and older
  • Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
  • Has AD involvement ? 5% Treatable %BSA (excluding the scalp)
  • Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
  • All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria:

  • As determined by the study doctor, a medical history that may interfere with study objectives
  • Unstable AD or any consistent requirement for high potency topical corticosteroids
  • History of use of biologic therapy (including intravenous immunoglobulin)
  • Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
  • Recent or current participation in another research study
  • Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
  • Participation in a previous AN2728 clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02118792
Other Study ID Numbers  ICMJE AN2728-AD-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP