Clinical Trial: Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

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

Official Title: An Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN2728 Ointment in Adolescents With Atopic Dermatitis

Brief Summary: The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Number of Participants With Local Tolerability Symptoms According to Severity on Baseline [ Time Frame: Baseline ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure.
  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 2 [ Time Frame: Day 2 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure.
  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 4 [ Time Frame: Day 4 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of par

    Original Primary Outcome: Assessment of safety and tolerability [ Time Frame: up to 28 days ]

    Descriptive summarization of safety and tolerability (frequency and severity of systemic and local AEs)


    Current Secondary Outcome:

    • Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) [ Time Frame: Baseline up to Day 29 ]
      ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. 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). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29.
    • Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22, 29 ]
      5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis.


    Original Secondary Outcome:

    • Profile of pharmacokinetics on Days 2,4,6,9 at timepoints 0,1,2,4,6,8 hrs post-dose [ Time Frame: Dosing days 2, 4, 6, 9 ]
      Cmax, Area Under Curve, Tmax, t1/2
    • Achievement of treatment success [ Time Frame: up to 28 days ]
      Achievement of treatment success (defined as a score of Clear or Almost Clear with a 2-grade improvement from Baseline) will be based on the ISGA, a 5-point scale from 0 (clear) to 4 (severe)
    • Improvement in the signs and symptoms of atopic dermatitis [ Time Frame: up to 28 days ]
      Improvement from Baseline in the signs and symptoms of AD, including erythema, excoriation, exudation, lichenification, and pruritus, will be based on a 4-point scale from 0 (none) to 3 (severe)


    Information By: Pfizer

    Dates:
    Date Received: July 20, 2012
    Date Started: July 2012
    Date Completion:
    Last Updated: March 12, 2017
    Last Verified: March 2017