Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02118766
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118766
Recruitment Status : Completed
First Posted : April 21, 2014
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 April 15, 2014
First Posted Date  ICMJE April 21, 2014
Results First Submitted Date  ICMJE January 9, 2017
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 that were absent before treatment or that worsened relative to pre-treatment state.
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29 [ Time Frame: Baseline, Day 29 ]
    Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.
  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29 [ Time Frame: Baseline, Day 29 ]
    Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium. Clinical significance of change from baseline value was determined by investigator.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 Measures  ICMJE
 (submitted: April 17, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: January 12, 2017)
  • Time to Improvement in Pruritus [ Time Frame: Baseline up to Day 29 ]
    Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29 [ Time Frame: Baseline, Day 29 ]
    The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Original Other Pre-specified Outcome Measures
 (submitted: April 17, 2014)
  • Time to improvement in pruritus in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Through 29 days ]
  • Dermatology related QoL scores in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ]
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
Official Title  ICMJE 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 Atopic Dermatitis
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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%
  • Drug: Matching vehicle control
Study Arms  ICMJE
  • Experimental: AN2728 Topical Ointment, 2%
    AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
    Intervention: Drug: AN2728 Topical Ointment, 2%
  • Placebo Comparator: Matching vehicle control
    Matching vehicle control, applied twice daily for up to 28 days
    Intervention: Drug: Matching vehicle control
Publications *

*   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: December 28, 2015)
763
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2014)
750
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females 2 years and older
  • Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka
  • Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
  • Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
  • All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria:

  • As determined by the study doctor, a medical history that may interfere with study objectives
  • Unstable AD or any consistent requirement for high potency topical corticosteroids
  • History of use of biologic therapy (including intravenous immunoglobulin)
  • Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
  • Recent or current participation in another research study
  • Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
  • Participation in a previous AN2728 clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02118766
Other Study ID Numbers  ICMJE AN2728-AD-301
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