Trial Outcomes & Findings for Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis (NCT NCT01301508)
NCT ID: NCT01301508
Last Updated: 2019-02-22
Results Overview
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.
COMPLETED
PHASE2
46 participants
Baseline (Day 1)
2019-02-22
Participant Flow
Participant milestones
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
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 Study
STARTED
|
21
|
25
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
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 Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 65 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
Greater Than 65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: The intent-to-treat (ITT) population included all randomized participants who received study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
Active Lesion
|
8.0 units on a scale
Standard Deviation 1.21
|
8.3 units on a scale
Standard Deviation 1.77
|
|
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
Vehicle Lesion
|
8.0 units on a scale
Standard Deviation 1.24
|
8.4 units on a scale
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: Day 14Population: ITT population included all randomized participants who received study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Atopic Dermatitis Severity Index (ADSI) Score at Day 14
Active Lesion
|
3.8 units on a scale
Standard Deviation 1.98
|
4.0 units on a scale
Standard Deviation 2.54
|
|
Atopic Dermatitis Severity Index (ADSI) Score at Day 14
Vehicle Lesion
|
5.4 units on a scale
Standard Deviation 2.73
|
5.6 units on a scale
Standard Deviation 3.17
|
PRIMARY outcome
Timeframe: Day 28Population: ITT population included all randomized participants who received study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Vehicle Lesion
|
4.3 units on a scale
Standard Deviation 3.54
|
5.1 units on a scale
Standard Deviation 3.33
|
|
Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Active Lesion
|
2.6 units on a scale
Standard Deviation 1.78
|
2.8 units on a scale
Standard Deviation 2.30
|
PRIMARY outcome
Timeframe: Day 42Population: ITT population included all randomized participants who received study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Atopic Dermatitis Severity Index (ADSI) Score at Day 42
Active Lesion
|
3.5 units on a scale
Standard Deviation 3.75
|
3.0 units on a scale
Standard Deviation 2.98
|
|
Atopic Dermatitis Severity Index (ADSI) Score at Day 42
Vehicle Lesion
|
3.1 units on a scale
Standard Deviation 3.12
|
4.6 units on a scale
Standard Deviation 3.57
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 28Population: ITT population included all randomized participants who received study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Greater Decrease in Active Lesion
|
71.4 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Greater Decrease in Vehicle Lesion
|
14.3 percentage of participants
|
20.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), Day 14, Day 42Population: ITT population included all randomized participants who received study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
Greater Decrease in Vehicle Lesion: Day 14
|
14.3 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
Greater Decrease in Vehicle Lesion: Day 42
|
42.9 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
Greater Decrease in Active Lesion: Day 14
|
57.1 percentage of participants
|
64.0 percentage of participants
|
|
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
Greater Decrease in Active Lesion: Day 42
|
47.6 percentage of participants
|
64.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) up to Day 42Population: Safety analysis population included all randomized participants with confirmed usage of the study medication.
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.
Outcome measures
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 Participants
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
11 participants
|
11 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
Adverse Events
AN2898 Ointment, 1% + Ointment Vehicle
AN2728 Ointment, 2% + Ointment Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AN2898 Ointment, 1% + Ointment Vehicle
n=21 participants at risk
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.
|
AN2728 Ointment, 2% + Ointment Vehicle
n=25 participants at risk
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.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/21
|
4.0%
1/25
|
|
General disorders
Application site erythema
|
4.8%
1/21
|
4.0%
1/25
|
|
General disorders
Application site irritation
|
0.00%
0/21
|
4.0%
1/25
|
|
General disorders
Application site pain
|
0.00%
0/21
|
4.0%
1/25
|
|
General disorders
Application site pruritus
|
4.8%
1/21
|
4.0%
1/25
|
|
General disorders
Fatigue
|
4.8%
1/21
|
0.00%
0/25
|
|
Infections and infestations
Application site cellulitis
|
4.8%
1/21
|
0.00%
0/25
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21
|
4.0%
1/25
|
|
Infections and infestations
Folliculitis
|
0.00%
0/21
|
4.0%
1/25
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21
|
4.0%
1/25
|
|
Infections and infestations
Herpes simplex
|
4.8%
1/21
|
0.00%
0/25
|
|
Infections and infestations
Influenza
|
4.8%
1/21
|
0.00%
0/25
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21
|
0.00%
0/25
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/21
|
4.0%
1/25
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
3/21
|
24.0%
6/25
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21
|
4.0%
1/25
|
|
Investigations
Blood creatinine increased
|
4.8%
1/21
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/21
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21
|
0.00%
0/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/21
|
4.0%
1/25
|
|
Nervous system disorders
Headache
|
4.8%
1/21
|
8.0%
2/25
|
|
Nervous system disorders
Migraine
|
4.8%
1/21
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.8%
1/21
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.8%
1/21
|
0.00%
0/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER