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

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NCT02118792

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Anacor Investigational Site
Henrico, Virginia, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT02118792
Pfizer
Completed
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis

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Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dermatitis, Atopic
  • Drug: AN2728 Topical Ointment, 2%
  • Drug: Matching vehicle control
  • 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
Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11. Erratum in: J Am Acad Dermatol. 2017 Apr;76(4):777.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
764
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02118792
AN2728-AD-302
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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