Dermatitis, Atopic
Conditions
Keywords
atopic dermatitis
Brief summary
The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
Interventions
AN2728 ointment, 2%, applied twice daily for 6 weeks
DRUGAN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
DRUGAN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
AN2728 ointment vehicle applied twice daily for 6 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month * Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin * Presence of two (2) comparable target lesions * Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits * Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.
Exclusion criteria
* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period * Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation * Significant confounding conditions as assessed by study doctor * History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis) * Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atopic Dermatitis Severity Index (ADSI) Score at Day 14 | Day 14 | 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. |
| Atopic Dermatitis Severity Index (ADSI) Score at Day 42 | Day 42 | 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 With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Baseline (Day 1), Day 28 | 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. |
| Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) | Baseline (Day 1) | 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. |
| Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Day 28 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Day 1) up to Day 42 | 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. |
| Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42 | Baseline (Day 1), Day 14, Day 42 | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle 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. | 21 |
| 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. | 25 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | AN2898 Ointment, 1% + Ointment Vehicle | AN2728 Ointment, 2% + Ointment Vehicle | Total |
|---|---|---|---|
| Age, Customized 18 to 65 years | 21 Participants | 22 Participants | 43 Participants |
| Age, Customized Greater Than 65 years | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 21 | 11 / 25 |
| serious Total, serious adverse events | 0 / 21 | 0 / 25 |
Outcome results
Primary
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
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)
Population: The intent-to-treat (ITT) population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) | Active Lesion | 8.0 units on a scale | Standard Deviation 1.21 |
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) | Vehicle Lesion | 8.0 units on a scale | Standard Deviation 1.24 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) | Active Lesion | 8.3 units on a scale | Standard Deviation 1.77 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) | Vehicle Lesion | 8.4 units on a scale | Standard Deviation 1.75 |
Primary
Atopic Dermatitis Severity Index (ADSI) Score at Day 14
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
Population: ITT population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 14 | Active Lesion | 3.8 units on a scale | Standard Deviation 1.98 |
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 14 | Vehicle Lesion | 5.4 units on a scale | Standard Deviation 2.73 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 14 | Active Lesion | 4.0 units on a scale | Standard Deviation 2.54 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 14 | Vehicle Lesion | 5.6 units on a scale | Standard Deviation 3.17 |
Primary
Atopic Dermatitis Severity Index (ADSI) Score at Day 28
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
Population: ITT population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Active Lesion | 2.6 units on a scale | Standard Deviation 1.78 |
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Vehicle Lesion | 4.3 units on a scale | Standard Deviation 3.54 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Active Lesion | 2.8 units on a scale | Standard Deviation 2.3 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Vehicle Lesion | 5.1 units on a scale | Standard Deviation 3.33 |
Primary
Atopic Dermatitis Severity Index (ADSI) Score at Day 42
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
Population: ITT population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 42 | Active Lesion | 3.5 units on a scale | Standard Deviation 3.75 |
| AN2898 Ointment, 1% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 42 | Vehicle Lesion | 3.1 units on a scale | Standard Deviation 3.12 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 42 | Active Lesion | 3.0 units on a scale | Standard Deviation 2.98 |
| AN2728 Ointment, 2% + Ointment Vehicle | Atopic Dermatitis Severity Index (ADSI) Score at Day 42 | Vehicle Lesion | 4.6 units on a scale | Standard Deviation 3.57 |
Primary
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
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
Population: ITT population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | 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 |
| AN2898 Ointment, 1% + Ointment Vehicle | 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 |
| AN2728 Ointment, 2% + Ointment Vehicle | Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Greater Decrease in Active Lesion | 68.0 percentage of participants |
| AN2728 Ointment, 2% + Ointment Vehicle | Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | Greater Decrease in Vehicle Lesion | 20.0 percentage of participants |
p-value: 0.008Two-sided sign test
p-value: 0.017Two-sided sign test
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Population: Safety analysis population included all randomized participants with confirmed usage of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 11 participants |
| AN2898 Ointment, 1% + Ointment Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| AN2728 Ointment, 2% + Ointment Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 11 participants |
| AN2728 Ointment, 2% + Ointment Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Other Pre-specified
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
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
Population: ITT population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2898 Ointment, 1% + Ointment Vehicle | 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 |
| AN2898 Ointment, 1% + Ointment Vehicle | 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 |
| AN2898 Ointment, 1% + Ointment Vehicle | 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 |
| AN2898 Ointment, 1% + Ointment Vehicle | 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 |
| AN2728 Ointment, 2% + Ointment Vehicle | 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 | 20.0 percentage of participants |
| AN2728 Ointment, 2% + Ointment Vehicle | 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 | 64.0 percentage of participants |
| AN2728 Ointment, 2% + Ointment Vehicle | 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 | 64.0 percentage of participants |
| AN2728 Ointment, 2% + Ointment Vehicle | 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 | 20.0 percentage of participants |