Clinical Trial: Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

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

Official Title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate

Brief Summary: The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) [ Time Frame: Baseline (Day 1) ]
    ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
  • Atopic Dermatitis Severity Index (ADSI) Score at Day 14 [ Time Frame: Day 14 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
  • Atopic Dermatitis Severity Index (ADSI) Score at Day 28 [ Time Frame: Day 28 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none

    Original Primary Outcome: AD lesions treated with AN2898 ointment or AN2728 ointment will have a greater decrease from Baseline in Atopic Dermatitis Severity Index (ADSI) score on Day 28 compared to lesions treated with the corresponding ointment vehicle [ Time Frame: Day 28 ]

    % of subjects where test article 1 performs better (greater decrease in ADSI score) than test article 2


    Current Secondary Outcome:

    Original Secondary Outcome:

    • AD lesions treated with AN2898 ointment will have a greater decrease from Baseline in ADSI on Day 28 compared to lesions treated with AN2728 ointment [ Time Frame: Day 28 ]
      % of subjects where test article 1 performs better (greater decrease in ADSI score) than test article 2
    • Number of participants with adverse events as a measure of safety and tolerability (systemic and local) of treatment for up to 42 days [ Time Frame: Up to 42 days ]


    Information By: Pfizer

    Dates:
    Date Received: February 17, 2011
    Date Started: May 2011
    Date Completion:
    Last Updated: January 12, 2017
    Last Verified: January 2017