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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01602341
First received: May 17, 2012
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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)

Condition Intervention Phase
Dermatitis, Atopic Drug: AN2728 Topical Ointment, 2% QD Drug: AN2728 Topical Ointment, 0.5% QD Drug: AN2728 Topical Ointment, 2% BID Drug: AN2728 Topical Ointment, 0.5% BID Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 86
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 2% QD
Drug: AN2728 Topical Ointment, 0.5% QD
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.

Drug: AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 2% BID
Drug: AN2728 Topical Ointment, 0.5% BID
AN2728 Topical Ointment, 0.5% BID

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602341

Locations
United States, California
Anacor Investigational Site
Fremont, California, United States
United States, Florida
Anacor Investigational Site
Miami, Florida, United States
United States, Kentucky
Anacor Investigational Site
Lousiville, Kentucky, United States
United States, Michigan
Anacor Investigational Site
Detroit, Michigan, United States
United States, New Mexico
Anacor Investigational Site
Albuquerque, New Mexico, United States
United States, New York
Anacor Investigational Site
Stony Brook, New York, United States
United States, North Carolina
Anacor Investigational Site
High Point, North Carolina, United States
United States, Oregon
Anacor Investigational Site
Portland, Oregon, United States
United States, Tennessee
Anacor Investigational Site
Knoxville, Tennessee, United States
United States, Utah
Anacor Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
Anacor Investigational Site
Norfolk, Virginia, United States
Australia, Australian Capital Territory
Anacor Investigational Site
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Anacor Investigational Site
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Anacor Investigational Site
Wooloongabba, Queensland, Australia
Australia, Victoria
Anacor Investigational Site
Box Hill, Victoria, Australia
Anacor Investigational Site
Parkville, Victoria, Australia
Australia, Western Australia
Anacor Investigational Site
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01602341     History of Changes
Other Study ID Numbers: AN2728-AD-204
Study First Received: May 17, 2012
Results First Received: January 11, 2017
Last Updated: January 12, 2017

Keywords provided by Pfizer:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 27, 2017