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Trial record 5 of 740 for:    "Dermatitis, Atopic"

Safety, Tolerability, and PK of AN2728 in Adolescents 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: NCT01652885
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Intervention Drug: AN2728 Topical Ointment, 2%
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate atopic dermatitis (AD), twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Period Title: Overall Study
Started 23
Completed 22
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
15.0  (1.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
19
  82.6%
Male
4
  17.4%
1.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Baseline
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 10
Mild 7
Moderate 6
Severe 0
2.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 2
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 17
Mild 5
Moderate 1
Severe 0
3.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 4
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 18
Mild 3
Moderate 2
Severe 0
4.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 6
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 18
Mild 4
Moderate 1
Severe 0
5.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 8
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 20
Mild 3
Moderate 0
Severe 0
6.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 9
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure.
Time Frame Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 18
Mild 4
Moderate 1
Severe 0
7.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 15
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 19
Mild 4
Moderate 0
Severe 0
8.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 22
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 21
Mild 2
Moderate 0
Severe 0
9.Primary Outcome
Title Number of Participants With Local Tolerability Symptoms According to Severity on Day 29
Hide Description Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
None 20
Mild 2
Moderate 0
Severe 1
10.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 in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline (Day 1) up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
AEs 10
SAEs 0
11.Primary Outcome
Title Number of Participants With Clinically Significant Vital Signs Abnormalities
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 (Day 1) up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
0
12.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Test 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 (Day 1) up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
0
13.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
Hide Description Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
AN2728 105  (160)
AN7602 28.2  (37.0)
AN8323 998  (1220)
14.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
Hide Description Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: hour
AN2728
2.37
(1.00 to 24.0)
AN7602
2.08
(1.00 to 24.0)
AN8323
6.25
(3.95 to 25.0)
15.Primary Outcome
Title Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
Hide Description Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter
AN2728 448  (527)
AN7602 142  (172)
AN8323 8900  (11600)
16.Primary Outcome
Title Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
Hide Description Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: hour
AN2728 (n =16) 7.17  (2.30)
AN7602 (n =18) 8.19  (5.13)
AN8323 (n =6) 17.7  (1.63)
17.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
Hide Description Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, "Number of Participants Analyzed" (N) signifies evaluable participants for this outcome measure.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
AN2728 94.6  (189)
AN7602 26.3  (43.9)
AN8323 1850  (1830)
18.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
Hide Description Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: hour
AN2728
2.17
(1.00 to 7.93)
AN7602
3.94
(1.00 to 6.15)
AN8323
6.00
(0.00 to 25.1)
19.Primary Outcome
Title Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
Hide Description Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter
AN2728 462  (506)
AN7602 142  (154)
AN8323 18200  (18100)
20.Primary Outcome
Title Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
Hide Description Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: hour
AN2728 (n =17) 11.9  (8.28)
AN7602 (n =16) 10.5  (6.38)
AN8323 (n =6) 33.5  (10.1)
21.Secondary Outcome
Title Number of Participants Who Achieved Treatment Success Based on Investigator’s Static Global Assessment (ISGA)
Hide Description ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. 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). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
9
  39.1%
22.Secondary Outcome
Title Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29
Hide Description 5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis.
Time Frame Baseline, Day 8, 15, 22, 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and had received any amount of the study drug.
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description:
AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Erythema 1.63  (0.607)
Change at Day 8: Erythema -0.63  (0.588)
Change at Day 15: Erythema -0.70  (0.617)
Change at Day 22: Erythema -0.87  (0.626)
Change at Day 29: Erythema -0.89  (0.673)
Baseline: Pruritus 1.87  (0.815)
Change at Day 8: Pruritus -1.11  (0.916)
Change at Day 15: Pruritus -1.11  (0.825)
Change at Day 22: Pruritus -1.15  (0.804)
Change at Day 29: Pruritus -1.30  (0.735)
Baseline: Exudation 0.33  (0.467)
Change at Day 8: Exudation -0.20  (0.328)
Change at Day 15: Exudation -0.20  (0.328)
Change at Day 22: Exudation -0.09  (0.492)
Change at Day 29: Exudation -0.07  (0.645)
Baseline: Excoriation 1.04  (0.689)
Change at Day 8: Excoriation -0.50  (0.603)
Change at Day 15: Excoriation -0.57  (0.728)
Change at Day 22: Excoriation -0.52  (0.805)
Change at Day 29: Excoriation -0.61  (0.852)
Baseline: Lichenification 1.67  (0.614)
Change at Day 8: Lichenification -0.54  (0.520)
Change at Day 15: Lichenification -0.59  (0.596)
Change at Day 22: Lichenification -0.85  (0.573)
Change at Day 29: Lichenification -0.78  (0.671)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AN2728 Topical Ointment 2 Percent
Hide Arm/Group Description AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
All-Cause Mortality
AN2728 Topical Ointment 2 Percent
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AN2728 Topical Ointment 2 Percent
Affected / at Risk (%)
Total   0/23 (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 Topical Ointment 2 Percent
Affected / at Risk (%)
Total   10/23 (43.48%) 
General disorders   
Application site dermatitis * 1  1/23 (4.35%) 
Application site discomfort * 1  1/23 (4.35%) 
Application site pain * 1  3/23 (13.04%) 
Infections and infestations   
Upper respiratory tract infection * 1  1/23 (4.35%) 
Injury, poisoning and procedural complications   
Arthropod bite * 1  1/23 (4.35%) 
Hand fracture * 1  1/23 (4.35%) 
Nervous system disorders   
Headache * 1  1/23 (4.35%) 
Migraine * 1  1/23 (4.35%) 
Reproductive system and breast disorders   
Dysmenorrhoea * 1 [1]  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Nasal congestion * 1  1/23 (4.35%) 
Nasopharyngitis * 1  3/23 (13.04%) 
Sinus congestion * 1  1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Milia * 1  1/23 (4.35%) 
Solar dermatitis * 1  1/23 (4.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
[1]
This event was gender specific.
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01652885     History of Changes
Other Study ID Numbers: AN2728-AD-203
A3191007 ( Other Identifier: Pfizer )
First Submitted: July 20, 2012
First Posted: July 30, 2012
Results First Submitted: January 11, 2017
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017