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Trial record 38 of 154 for:    Dermatitis, Atopic, 8

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions 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
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Period Title: Overall Study
Started 44 42
Completed 44 41
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily Total
Hide Arm/Group Description AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. Total of all reporting groups
Overall Number of Baseline Participants 44 42 86
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized and received study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 42 participants 86 participants
<=18 years
44
 100.0%
42
 100.0%
86
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 42 participants 86 participants
Female
29
  65.9%
23
  54.8%
52
  60.5%
Male
15
  34.1%
19
  45.2%
34
  39.5%
1.Primary Outcome
Title Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
Hide Description 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.
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent, Once Daily AN2728 Ointment 2 Percent, Once Daily AN2728 Ointment 0.5 Percent, Twice Daily AN2728 Ointment 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.22  (1.891) 8.02  (1.852) 8.13  (1.811) 8.19  (1.811)
Improvement at Day 8 2.80  (2.431) 3.63  (1.695) 4.33  (2.208) 4.81  (1.972)
2.Primary Outcome
Title Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
Hide Description 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.
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent, Once Daily AN2728 Ointment 2 Percent, Once Daily AN2728 Ointment 0.5 Percent, Twice Daily AN2728 Ointment 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.02  (2.781) 4.34  (2.394) 4.51  (2.400) 5.36  (2.028)
3.Primary Outcome
Title Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
Hide Description 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.
Time Frame Baseline, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants, who were randomized and received study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent, Once Daily AN2728 Ointment 2 Percent, Once Daily AN2728 Ointment 0.5 Percent, Twice Daily AN2728 Ointment 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.86  (3.157) 4.55  (2.551) 4.70  (2.271) 5.49  (1.803)
4.Primary Outcome
Title Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
Hide Description 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.
Time Frame Baseline, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent, Once Daily AN2728 Ointment 2 Percent, Once Daily AN2728 Ointment 0.5 Percent, Twice Daily AN2728 Ointment 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.47  (3.185) 5.07  (2.214) 5.06  (2.361) 5.81  (1.714)
5.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description 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.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 42
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Hide Description 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.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 42
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.3%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 42
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
6
  13.6%
11
  26.2%
SAEs
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events By Severity
Hide Description 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.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 42
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
6
  13.6%
9
  21.4%
Moderate
0
   0.0%
2
   4.8%
Severe
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Local Tolerability Symptoms
Hide Description Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 42
Measure Type: Count of Participants
Unit of Measure: Participants
3
   6.8%
1
   2.4%
10.Secondary Outcome
Title Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
Hide Description 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.
Time Frame Baseline, Day 8, 15, 22, 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug.
Arm/Group Title AN2728 Ointment 0.5 Percent, Once Daily AN2728 Ointment 2 Percent, Once Daily AN2728 Ointment 0.5 Percent, Twice Daily AN2728 Ointment 2 Percent, Twice Daily
Hide Arm/Group Description:
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Erythema: Baseline 2.23  (0.314) 2.14  (0.272) 2.12  (0.216) 2.15  (0.259)
Erythema: Improvement at Day 8 0.75  (0.678) 0.90  (0.596) 0.93  (0.620) 1.10  (0.637)
Erythema: Improvement at Day 15 1.06  (0.787) 1.14  (0.702) 1.13  (0.716) 1.36  (0.647)
Erythema: Improvement at Day 22 1.02  (0.835) 1.17  (0.690) 1.11  (0.610) 1.40  (0.627)
Erythema: Improvement at Day 29 1.17  (0.785) 1.17  (0.646) 1.26  (0.718) 1.44  (0.636)
Excoriation: Baseline 1.43  (0.818) 1.41  (0.851) 1.50  (0.819) 1.50  (0.819)
Excoriation: Improvement at Day 8 0.49  (0.832) 0.74  (0.633) 0.88  (0.739) 1.02  (0.724)
Excoriation: Improvement at Day 15 0.82  (0.778) 0.78  (0.831) 0.86  (0.710) 1.06  (0.790)
Excoriation: Improvement at Day 22 0.68  (0.922) 0.88  (0.897) 0.95  (0.731) 1.08  (0.803)
Excoriation: Improvement at Day 29 0.82  (0.934) 1.03  (0.824) 0.96  (0.727) 1.17  (0.687)
Exudation: Baseline 0.77  (0.694) 0.75  (0.703) 0.75  (0.751) 0.80  (0.773)
Exudation: Improvement at Day 8 0.31  (0.531) 0.49  (0.586) 0.48  (0.643) 0.61  (0.668)
Exudation: Improvement at Day 15 0.40  (0.782) 0.51  (0.796) 0.42  (0.732) 0.54  (0.657)
Exudation: Improvement at Day 22 0.40  (0.825) 0.49  (0.818) 0.38  (0.688) 0.57  (0.630)
Exudation: Improvement at Day 29 0.40  (0.839) 0.57  (0.752) 0.42  (0.706) 0.64  (0.710)
Lichenification: Baseline 1.67  (0.715) 1.58  (0.777) 1.60  (0.692) 1.58  (0.723)
Lichenification: Improvement at Day 8 0.44  (0.508) 0.45  (0.480) 0.65  (0.535) 0.60  (0.544)
Lichenification: Improvement at Day 15 0.64  (0.554) 0.59  (0.622) 0.70  (0.644) 0.80  (0.681)
Lichenification: Improvement at Day 22 0.55  (0.627) 0.63  (0.630) 0.71  (0.554) 0.77  (0.646)
Lichenification: Improvement at Day 29 0.74  (0.651) 0.73  (0.686) 0.79  (0.750) 0.86  (0.701)
Pruritus: Baseline 2.13  (0.582) 2.15  (0.625) 2.17  (0.537) 2.17  (0.502)
Pruritus: Improvement at Day 8 0.82  (0.941) 1.05  (0.855) 1.39  (0.753) 1.50  (0.812)
Pruritus: Improvement at Day 15 1.11  (0.982) 1.32  (0.857) 1.40  (0.835) 1.62  (0.810)
Pruritus: Improvement at Day 22 1.23  (1.026) 1.39  (0.862) 1.55  (0.832) 1.67  (0.770)
Pruritus: Improvement at Day 29 1.35  (1.108) 1.57  (0.962) 1.63  (0.699) 1.71  (0.616)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Hide Arm/Group Description AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
All-Cause Mortality
AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/42 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/44 (13.64%)      11/42 (26.19%)    
General disorders     
Application site pain * 1  2/44 (4.55%)  2 0/42 (0.00%)  0
Application site pruritus * 1  1/44 (2.27%)  1 1/42 (2.38%)  1
Pain * 1  1/44 (2.27%)  1 0/42 (0.00%)  0
Infections and infestations     
Cellulitis * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Nasopharyngitis * 1  1/44 (2.27%)  1 2/42 (4.76%)  2
Tonsillitis * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Upper respiratory tract infection * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Urinary tract infection * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Viral upper respiratory tract infection * 1  1/44 (2.27%)  1 1/42 (2.38%)  1
Injury, poisoning and procedural complications     
Thermal burn * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal chest pain * 1  1/44 (2.27%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/44 (2.27%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
Dermatitis atopic * 1  0/44 (0.00%)  0 1/42 (2.38%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 001-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01602341     History of Changes
Other Study ID Numbers: AN2728-AD-204
First Submitted: May 17, 2012
First Posted: May 21, 2012
Results First Submitted: January 11, 2017
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017