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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29 [ Time Frame: Day 29 ]
    ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) [ Time Frame: AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36 ]
    An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study

    Original Primary Outcome: Primary Efficacy Endpoint: Proportion of subjects achieving success in ISGA at Day 29 in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ]

    Current Secondary Outcome:

    • Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29 [ Time Frame: Day 29 ]
      ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.
    • Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA) [ Time Frame: Baseline (Day 1) up to Day 29 ]
      Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.
    • Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29 [ Time Frame: Baseline, Day 29 ]
      Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.


    Original Secondary Outcome:

    • Primary Safety Endpoint: Frequency of TEAEs, SAEs, and clinically significant changes in vital signs and clinical laboratory parameters in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Through 36 days ]
    • Proportion of subjects with an ISGA score of Clear (0) or Almost Clear (1) at Day 29 in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ]
    • Time to success in ISGA in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Through 29 days ]
    • Change from baseline in signs of AD in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ]


    Information By: Pfizer

    Dates:
    Date Received: April 15, 2014
    Date Started: March 2014
    Date Completion:
    Last Updated: January 12, 2017
    Last Verified: January 2017