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Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01301508
First received: February 17, 2011
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Condition Intervention Phase
Dermatitis, Atopic Drug: AN2728 ointment, 2% Drug: AN2898 ointment, 1% Drug: AN2898 ointment vehicle Drug: AN2728 ointment vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) [ Time Frame: Baseline (Day 1) ]
    ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.

  • Atopic Dermatitis Severity Index (ADSI) Score at Day 14 [ Time Frame: Day 14 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.

  • Atopic Dermatitis Severity Index (ADSI) Score at Day 28 [ Time Frame: Day 28 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.

  • Atopic Dermatitis Severity Index (ADSI) Score at Day 42 [ Time Frame: Day 42 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.

  • Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 [ Time Frame: Baseline (Day 1), Day 28 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.


Other Outcome Measures:
  • Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42 [ Time Frame: Baseline (Day 1), Day 14, Day 42 ]
    ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Days 14, 42 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Days 14, 42 as compared to active lesion (ointment treated) were reported in this outcome measure.

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Day 1) up to Day 42 ]
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The 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 or incapacity, congenital anomaly. Treatment-emergent were events between first dose of study medication and up to the end of study treatment (Day 42) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.


Enrollment: 46
Study Start Date: May 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2898 ointment, 1%, vs. ointment vehicle

AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

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

Drug: AN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
Drug: AN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
Experimental: AN2728 ointment, 2%, vs. ointment vehicle

AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

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

Drug: AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 6 weeks
Drug: AN2728 ointment vehicle
AN2728 ointment vehicle applied twice daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
  • Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
  • Presence of two (2) comparable target lesions
  • Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
  • Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria:

  • Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
  • Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
  • Significant confounding conditions as assessed by study doctor
  • History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • Pregnancy or lactation
  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: NCT01301508

Locations
Australia, New South Wales
Anacor Investigational Site
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Anacor Investigational Site
Brisbane, Queensland, Australia, 4000
Anacor Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Anacor Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Anacor Investigational Site
Box Hill, Victoria, Australia, 3128
Anacor Investigational Site
Carlton, Victoria, Australia, 3053
Anacor Investigational Site
Clayton, Victoria, Australia, 3168
Anacor Investigational Site
Fitzroy, Victoria, Australia, 3065
Anacor Investigational Site
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Anacor Investigational Site
Fremantle, Western Australia, Australia, 6160
Anacor Investigational Site
Nedlands, Western Australia, Australia, 6009
Anacor Investigational Site
Subiaco, Western Australia, Australia, 6008
Anacor Investigational Site
Victoria Park, Western Australia, Australia, 6100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01301508     History of Changes
Other Study ID Numbers: AN2898-AD-202
C3471001 ( Other Identifier: Pfizer )
Study First Received: February 17, 2011
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 September 21, 2017