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

NCT02118766

Last updated date
Study Location
Anacor Investigational Site
Stockbridge, Georgia, , United States
Contact
1-800-718-1021

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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 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 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)
763
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 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 NCT02118766
Other Study ID Numbers  ICMJE AN2728-AD-301
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