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Trial record 1 of 1 for:    NCT01602341
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Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01602341
Recruitment Status : Completed
First Posted : May 21, 2012
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 17, 2012
First Posted Date  ICMJE May 21, 2012
Results First Submitted Date  ICMJE January 11, 2017
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 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 29 [ Time Frame: Baseline, Day 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 score minus follow-up score.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
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)
Change History Complete list of historical versions of study NCT01602341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 Measures  ICMJE
 (submitted: May 17, 2012)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
Official Title  ICMJE 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 Atopic Dermatitis
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: AN2728 Topical Ointment, 2% QD
    AN2728 Topical Ointment, 2% QD
  • Drug: AN2728 Topical Ointment, 0.5% QD
    AN2728 Topical Ointment, 0.5% QD
  • Drug: AN2728 Topical Ointment, 2% BID
    AN2728 Topical Ointment, 2% BID
  • Drug: AN2728 Topical Ointment, 0.5% BID
    AN2728 Topical Ointment, 0.5% BID
Study Arms  ICMJE
  • Experimental: AN2728 Topical Ointment, 2% QD vs 0.5% QD

    AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion

    Treatments will be randomly assigned to target lesions A and B.

    Interventions:
    • Drug: AN2728 Topical Ointment, 2% QD
    • Drug: AN2728 Topical Ointment, 0.5% QD
  • Experimental: AN2728 Topical Ointment, 2% BID vs 0.5% BID

    AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion.

    Treatments will be randomly assigned to target lesions A and B.

    Interventions:
    • Drug: AN2728 Topical Ointment, 2% BID
    • Drug: AN2728 Topical Ointment, 0.5% BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2012)
80
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female 12 to 17 years of age, inclusive
  • Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
  • Total body surface area (BSA) of atopic dermatitis involvement ≤35%
  • Presence of two comparable target lesions
  • Willing and able to comply with study instructions and commit to attending all visits
  • Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
  • Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion Criteria:

  • Significant confounding conditions as assessed by study doctor
  • Unstable or actively infected AD
  • Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
  • History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
  • Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
  • Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
  • Current pregnancy or lactation, or intent to become pregnant during the study
  • Known sensitivity to any of the components of the study drug
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • Participated in a previous AN2728 clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602341
Other Study ID Numbers  ICMJE AN2728-AD-204
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP