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Trial record 11 of 737 for:    "Dermatitis, Atopic"

Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate 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: NCT01301508
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : March 7, 2017
Last Update Posted : February 22, 2019
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 ointment, 2%
Drug: AN2898 ointment, 1%
Drug: AN2898 ointment vehicle
Drug: AN2728 ointment vehicle
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description Participants with mild to moderate atopic dermatitis (AD) applied AN2898 ointment, 1 percent (%) to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator. Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Period Title: Overall Study
Started 21 25
Completed 20 22
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             0             1
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle Total
Hide Arm/Group Description Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator. Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator. Total of all reporting groups
Overall Number of Baseline Participants 21 25 46
Hide Baseline Analysis Population Description
Safety analysis population included all randomized participants with confirmed usage of the study medication.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 25 participants 46 participants
18 to 65 years
21
 100.0%
22
  88.0%
43
  93.5%
Greater Than 65 years
0
   0.0%
3
  12.0%
3
   6.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 25 participants 46 participants
Female
11
  52.4%
10
  40.0%
21
  45.7%
Male
10
  47.6%
15
  60.0%
25
  54.3%
1.Primary Outcome
Title Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
Hide Description ADSI score was used to measure the severity of participant’s atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Active Lesion 8.0  (1.21) 8.3  (1.77)
Vehicle Lesion 8.0  (1.24) 8.4  (1.75)
2.Primary Outcome
Title Atopic Dermatitis Severity Index (ADSI) Score at Day 14
Hide Description ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Active Lesion 3.8  (1.98) 4.0  (2.54)
Vehicle Lesion 5.4  (2.73) 5.6  (3.17)
3.Primary Outcome
Title Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Hide Description ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Active Lesion 2.6  (1.78) 2.8  (2.30)
Vehicle Lesion 4.3  (3.54) 5.1  (3.33)
4.Primary Outcome
Title Atopic Dermatitis Severity Index (ADSI) Score at Day 42
Hide Description ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Active Lesion 3.5  (3.75) 3.0  (2.98)
Vehicle Lesion 3.1  (3.12) 4.6  (3.57)
5.Primary Outcome
Title Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Hide Description ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.
Time Frame Baseline (Day 1), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Measure Type: Number
Unit of Measure: percentage of participants
Greater Decrease in Active Lesion 71.4 68.0
Greater Decrease in Vehicle Lesion 14.3 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2898 Ointment, 1% + Ointment Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.
Method Two-sided sign test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AN2728 Ointment, 2% + Ointment Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.
Method Two-sided sign test
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
Hide Description ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Days 14, 42 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Days 14, 42 as compared to active lesion (ointment treated) were reported in this outcome measure.
Time Frame Baseline (Day 1), Day 14, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Measure Type: Number
Unit of Measure: percentage of participants
Greater Decrease in Active Lesion: Day 14 57.1 64.0
Greater Decrease in Vehicle Lesion: Day 14 14.3 20.0
Greater Decrease in Active Lesion: Day 42 47.6 64.0
Greater Decrease in Vehicle Lesion: Day 42 42.9 20.0
7.Other Pre-specified 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 treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of study medication and up to the end of study treatment (Day 42) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame Baseline (Day 1) up to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants with confirmed usage of the study medication.
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description:
Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 21 25
Measure Type: Number
Unit of Measure: participants
AEs 11 11
SAEs 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Hide Arm/Group Description Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator. Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
All-Cause Mortality
AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AN2898 Ointment, 1% + Ointment Vehicle AN2728 Ointment, 2% + Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   11/21 (52.38%)   11/25 (44.00%) 
Ear and labyrinth disorders     
Ear pain * 1  0/21 (0.00%)  1/25 (4.00%) 
General disorders     
Application site erythema * 1  1/21 (4.76%)  1/25 (4.00%) 
Application site irritation * 1  0/21 (0.00%)  1/25 (4.00%) 
Application site pain * 1  0/21 (0.00%)  1/25 (4.00%) 
Application site pruritus * 1  1/21 (4.76%)  1/25 (4.00%) 
Fatigue * 1  1/21 (4.76%)  0/25 (0.00%) 
Infections and infestations     
Application site cellulitis * 1  1/21 (4.76%)  0/25 (0.00%) 
Bronchitis * 1  0/21 (0.00%)  1/25 (4.00%) 
Folliculitis * 1  0/21 (0.00%)  1/25 (4.00%) 
Gastroenteritis * 1  0/21 (0.00%)  1/25 (4.00%) 
Herpes simplex * 1  1/21 (4.76%)  0/25 (0.00%) 
Influenza * 1  1/21 (4.76%)  0/25 (0.00%) 
Nasopharyngitis * 1  1/21 (4.76%)  0/25 (0.00%) 
Tonsillitis * 1  0/21 (0.00%)  1/25 (4.00%) 
Upper respiratory tract infection * 1  3/21 (14.29%)  6/25 (24.00%) 
Urinary tract infection * 1  0/21 (0.00%)  1/25 (4.00%) 
Investigations     
Blood creatinine increased * 1  1/21 (4.76%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Gout * 1  0/21 (0.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/21 (4.76%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma * 1  0/21 (0.00%)  1/25 (4.00%) 
Nervous system disorders     
Headache * 1  1/21 (4.76%)  2/25 (8.00%) 
Migraine * 1  1/21 (4.76%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  1/21 (4.76%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  1/21 (4.76%)  1/25 (4.00%) 
Pruritus generalised * 1  1/21 (4.76%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01301508     History of Changes
Other Study ID Numbers: AN2898-AD-202
C3471001 ( Other Identifier: Pfizer )
First Submitted: February 17, 2011
First Posted: February 23, 2011
Results First Submitted: January 11, 2017
Results First Posted: March 7, 2017
Last Update Posted: February 22, 2019