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Trial record 80 of 154 for:    Dermatitis, Atopic, 8

Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 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: NCT02118792
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

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%
Drug: Matching vehicle control
Enrollment 764
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2728 Ointment, 2 Percent (%) AN2728 Ointment, Vehicle
Hide Arm/Group Description AN2728 ointment, 2% was applied topically twice daily, to all treatable atopic dermatitis (AD)-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator. AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Period Title: Overall Study
Started 514 250
Treated 513 250
Completed 483 213
Not Completed 31 37
Reason Not Completed
Withdrawal by Subject             6             3
Lost to Follow-up             4             4
Adverse Event             5             4
Withdrawal by parent/guardian             14             20
Other             1             6
Randomised but not treated             1             0
Arm/Group Title AN2728 Ointment, 2 Percent (%) AN2728 Ointment, Vehicle Total
Hide Arm/Group Description AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator. AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator. Total of all reporting groups
Overall Number of Baseline Participants 513 250 763
Hide Baseline Analysis Population Description
Intent to Treat (ITT) population included all participants who were randomized and received study drug.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 513 participants 250 participants 763 participants
2 -11 years
310
  60.4%
164
  65.6%
474
  62.1%
12 -17 years
126
  24.6%
57
  22.8%
183
  24.0%
>=18 years
77
  15.0%
29
  11.6%
106
  13.9%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 513 participants 250 participants 763 participants
Female
282
  55.0%
138
  55.2%
420
  55.0%
Male
231
  45.0%
112
  44.8%
343
  45.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29
Hide Description ISGA assessed the severity of AD (except scalp) 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.
Time Frame 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, 2 Percent (%) AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 513 250
Measure Type: Number
Unit of Measure: percentage of participants
31.4 18.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2728 Ointment, 2 Percent (%), AN2728 Ointment, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Primary 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 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 to the end of study, that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.
Arm/Group Title AN2728 Ointment, 2 Percent (%) AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 510 247
Measure Type: Number
Unit of Measure: participants
AEs 150 79
SAEs 3 0
3.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8
Hide Description ECG parameters that were analyzed: PR interval, QRS interval, QT interval and corrected QT interval based on Fridericia’s formula (QTcF). Clinical significance of change from baseline in ECG findings was determined by investigator.
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.
Arm/Group Title AN2728 Ointment, 2 Percent (%) AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 510 247
Measure Type: Number
Unit of Measure: participants
0 0
4.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36
Hide Description Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position and after the participant had been calmly sitting or lying face up for a minimum of 5 minutes. Clinical significance of change from baseline value was determined by investigator.
Time Frame Baseline (Day 1), Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.
Arm/Group Title AN2728 Ointment, 2 Percent (%) AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 510 247
Measure Type: Number
Unit of Measure: participants
0 0
5.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Values
Hide Description Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Bilirubin, Blood Urea Nitrogen, Glucose, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Erythrocytes, Potassium, Protein, Sodium. Clinically significant laboratory abnormalities were defined as abnormal laboratory test values that have clinical manifestations or require medical intervention, as per investigator’s discretion.
Time Frame Baseline up to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 510 247
Measure Type: Number
Unit of Measure: participants
4 4
6.Primary Outcome
Title Percentage of Participants With Local Tolerability Symptoms at Baseline
Hide Description Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 509 247
Measure Type: Number
Unit of Measure: percentage of participants
None 48.7 56.3
Mild 23.8 21.9
Moderate 19.6 16.6
Severe 7.9 5.3
7.Primary Outcome
Title Percentage of Participants With Local Tolerability Symptoms at Day 8
Hide Description Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 508 244
Measure Type: Number
Unit of Measure: percentage of participants
None 63.8 73.0
Mild 24.0 14.8
Moderate 9.1 11.5
Severe 3.1 0.8
8.Primary Outcome
Title Percentage of Participants With Local Tolerability Symptoms at Day 15
Hide Description Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1= mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, "N" signifies those participants who were analyzed in this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 488 239
Measure Type: Number
Unit of Measure: percentage of participants
None 68.0 70.7
Mild 20.9 15.5
Moderate 7.4 9.6
Severe 3.7 4.2
9.Primary Outcome
Title Percentage of Participants With Local Tolerability Symptoms at Day 22
Hide Description Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. In this outcome, percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed "N" signifies those participants who were analyzed in this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 487 227
Measure Type: Number
Unit of Measure: percentage of participants
None 69.0 71.4
Mild 21.8 16.7
Moderate 6.8 8.4
Severe 2.5 3.5
10.Primary Outcome
Title Percentage of Participants With Local Tolerability Symptoms at Day 29
Hide Description Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 486 222
Measure Type: Number
Unit of Measure: percentage of participants
None 70.4 73.9
Mild 17.3 13.5
Moderate 10.1 10.8
Severe 2.3 1.8
11.Primary Outcome
Title Percentage of Participants With Local Tolerability Symptoms at Day 36
Hide Description Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.
Time Frame Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 474 213
Measure Type: Number
Unit of Measure: percentage of participants
None 71.1 77.5
Mild 14.3 9.9
Moderate 9.1 10.3
Severe 5.5 2.3
12.Secondary Outcome
Title Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29
Hide Description 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 Frame 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 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 513 250
Measure Type: Number
Unit of Measure: percentage of participants
48.5 29.7
13.Secondary Outcome
Title Time to Achieve Treatment Success Based on Investigator’s Static Global Assessment (ISGA)
Hide Description 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.
Time Frame Baseline up to 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 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 513 250
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
The median time to achieve success in ISGA and its 95% confidence interval (CI) were not estimable, as fewer participants (less than 50 percent) reached success in ISGA.
[2]
The median time to achieve success in ISGA and its 95% CI were not estimable, as fewer participants (less than 50 percent) reached success in ISGA.
14.Secondary Outcome
Title Change From Baseline in Signs of Atopic Dermatitis at Day 29
Hide Description 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.
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. Here, 'n' signifies those participants who were evaluable at specific time point for each arm.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 513 250
Mean (Standard Deviation)
Unit of Measure: units on a scale
Erythema: Baseline (n =513, 250) 1.7  (0.59) 1.6  (0.59)
Erythema: Change at Day 29 (n =486, 224) -0.7  (0.79) -0.3  (0.81)
Induration: Baseline (n =513, 250) 1.8  (0.61) 1.8  (0.56)
Induration: Change at Day 29 (n =486, 224) -0.7  (0.83) -0.4  (0.76)
Exudation: Baseline (n =513, 250) 0.7  (0.78) 0.6  (0.81)
Exudation: Change at Day 29 (n =486, 224) -0.4  (0.80) -0.1  (0.84)
Excoriation: Baseline (n =513, 250) 1.5  (0.72) 1.5  (0.68)
Excoriation: Change at Day 29 (n =486, 224) -0.7  (0.89) -0.5  (0.93)
Lichenification: Baseline (n =513, 250) 1.5  (0.68) 1.5  (0.76)
Lichenification: Change at Day 29 (n =486, 224) -0.6  (0.80) -0.3  (0.76)
15.Other Pre-specified Outcome
Title Time to Improvement in Pruritus
Hide Description 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.
Time Frame Baseline (Day 1) up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug. Here, "N'' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 439 211
Median (95% Confidence Interval)
Unit of Measure: days
1.41
(1.23 to 1.66)
1.54
(1.20 to 1.93)
16.Other Pre-specified Outcome
Title Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) Score at Day 29
Hide Description The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children’s (aged 2-15 years) 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 CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children’s life; 2-6 = small effect on the children’s life; 7-12 = moderate effect on the children’s life; 13-18 = very large effect on the children’s life; 19-30 = extremely large effect on the children’s life. Higher scores indicate more impact on quality of life of children.
Time Frame Baseline (Day 1), Day 29
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Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
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AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 404 204
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =404, 204) 9.0  (5.77) 8.9  (5.48)
Change at Day 29 (n =376,180) -4.0  (4.92) -2.9  (5.01)
17.Other Pre-specified Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29
Hide Description 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.
Time Frame Baseline (Day 1), Day 29
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Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 97 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =97, 40) 9.7  (6.24) 9.1  (6.67)
Change at Day 29 (n =93, 38) -5.0  (5.49) -3.4  (4.75)
18.Other Pre-specified Outcome
Title Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score at Day 29
Hide Description The DFI was a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It was completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question was scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score was the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.
Time Frame Baseline (Day 1), Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 431 217
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =431, 217) 7.7  (6.57) 8.0  (5.65)
Change at Day 29 (n =404, 190) -3.6  (5.18) -2.8  (4.75)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were analyzed for safety population which included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.
 
Arm/Group Title AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Hide Arm/Group Description AN2728 ointment 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator. AN2728 ointment vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
All-Cause Mortality
AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   3/510 (0.59%)   0/247 (0.00%) 
Infections and infestations     
Application site infection * 1  1/510 (0.20%)  0/247 (0.00%) 
Injury, poisoning and procedural complications     
Laceration * 1  1/510 (0.20%)  0/247 (0.00%) 
Psychiatric disorders     
Suicidal ideation * 1  1/510 (0.20%)  0/247 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AN2728 Topical Ointment, 2 Percent (%) AN2728 Topical Ointment, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   92/510 (18.04%)   54/247 (21.86%) 
Gastrointestinal disorders     
Diarrhoea * 1  6/510 (1.18%)  2/247 (0.81%) 
Vomiting * 1  7/510 (1.37%)  2/247 (0.81%) 
General disorders     
Application site pain * 1  14/510 (2.75%)  3/247 (1.21%) 
Application site pruritus * 1  1/510 (0.20%)  3/247 (1.21%) 
Application site urticaria * 1  0/510 (0.00%)  3/247 (1.21%) 
Pyrexia * 1  7/510 (1.37%)  4/247 (1.62%) 
Infections and infestations     
Nasopharyngitis * 1  9/510 (1.76%)  6/247 (2.43%) 
Staphylococcal skin infection * 1  1/510 (0.20%)  4/247 (1.62%) 
Upper respiratory tract infection * 1  16/510 (3.14%)  5/247 (2.02%) 
Nervous system disorders     
Headache * 1  6/510 (1.18%)  1/247 (0.40%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  7/510 (1.37%)  7/247 (2.83%) 
Oropharyngeal pain * 1  7/510 (1.37%)  2/247 (0.81%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic * 1  4/510 (0.78%)  6/247 (2.43%) 
Eczema * 1  3/510 (0.59%)  3/247 (1.21%) 
Pruritus * 1  4/510 (0.78%)  3/247 (1.21%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
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
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02118792     History of Changes
Other Study ID Numbers: AN2728-AD-302
First Submitted: April 15, 2014
First Posted: April 21, 2014
Results First Submitted: January 5, 2017
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017