Clinical Trial: Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

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

Official Title: A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With

Brief Summary: The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8 [ Time Frame: Baseline, Day 8 ]
    ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
  • Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15 [ Time Frame: Baseline, Day 15 ]
    ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
  • Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22 [ Time Frame: Baseline, Day 22 ]
    ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each su

    Original Primary Outcome: Change from Baseline in ADSI score compared between 0.5% and 2% ointment applied QD or BID for up to 29 days [ Time Frame: Days 8, 15, 22, and 29 ]

    % of subjects where one concentration or dosing schedule performs better (greater decrease in ADSI score)


    Current Secondary Outcome:

    • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to Day 29 ]
      Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.
    • Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline up to Day 29 ]
      Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.
    • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 29 ]
      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is 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 to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.
    • Number of Participants With Treatment-Emergent Adverse Events By Severity [ Time Frame: Baseline up to Day 29 ]
      AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.
    • Number of Participants With Local Tolerability Symptoms [ Time Frame: Baseline up to Day 29 ]
      Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.
    • Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22, 29 ]
      ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.


    Original Secondary Outcome:

    • Number of participants with adverse events as a measure of safety and tolerability (systemic and local) of treatment for up to 29 days [ Time Frame: Up to 29 days ]
    • Differences in ADSI component subscores compared between 0.5% and 2% ointment applied QD or BID for up to 29 days [ Time Frame: Up to 29 days ]


    Information By: Pfizer

    Dates:
    Date Received: May 17, 2012
    Date Started: August 2012
    Date Completion:
    Last Updated: January 12, 2017
    Last Verified: January 2017