| 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. | The intent-to-treat (ITT) population included all randomized participants who received study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Active Lesion | | | Title | Measurements |
|---|
| - OG0008.0± 1.21
- OG0018.3± 1.77
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| | Vehicle Lesion | | |
| |
| 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. | ITT population included all randomized participants who received study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | ITT population included all randomized participants who received study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | ITT population included all randomized participants who received study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | ITT population included all randomized participants who received study medication. | Posted | | Number | | percentage of participants | | Baseline (Day 1), Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | AN2728 Ointment, 2% + Ointment Vehicle |
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| 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. | ITT population included all randomized participants who received study medication. | Posted | | Number | | percentage of participants | | Baseline (Day 1), Day 14, Day 42 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | AN2728 Ointment, 2% + Ointment Vehicle |
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| 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. | Safety analysis population included all randomized participants with confirmed usage of the study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 42 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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