Trial Outcomes & Findings for Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis (NCT NCT01602341)

NCT ID: NCT01602341

Last Updated: 2017-03-06

Results Overview

ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 86 participants
• Primary outcome timeframe: Baseline, Day 8
• Results posted on: 2017-03-06

Participant Flow

Participant milestones

Measure	AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Study STARTED	44	42
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Overall Study Adverse Event	0	1

Baseline Characteristics

Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

Baseline characteristics by cohort

Measure	AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	44 Participants n=93 Participants	42 Participants n=4 Participants	86 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Gender Female	29 Participants n=93 Participants	23 Participants n=4 Participants	52 Participants n=27 Participants
Gender Male	15 Participants n=93 Participants	19 Participants n=4 Participants	34 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Day 8

Population: ITT population included all participants who were randomized and received study drug.

ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=44 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8 Baseline	8.22 units on a scale Standard Deviation 1.891	8.02 units on a scale Standard Deviation 1.852	8.13 units on a scale Standard Deviation 1.811	8.19 units on a scale Standard Deviation 1.811
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8 Improvement at Day 8	2.80 units on a scale Standard Deviation 2.431	3.63 units on a scale Standard Deviation 1.695	4.33 units on a scale Standard Deviation 2.208	4.81 units on a scale Standard Deviation 1.972

PRIMARY outcome

Timeframe: Baseline, Day 15

Population: ITT population included all participants who were randomized and received study drug.

ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=44 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	4.02 units on a scale Standard Deviation 2.781	4.34 units on a scale Standard Deviation 2.394	4.51 units on a scale Standard Deviation 2.400	5.36 units on a scale Standard Deviation 2.028

PRIMARY outcome

Timeframe: Baseline, Day 22

Population: ITT population included all participants, who were randomized and received study drug.

ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=44 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	3.86 units on a scale Standard Deviation 3.157	4.55 units on a scale Standard Deviation 2.551	4.70 units on a scale Standard Deviation 2.271	5.49 units on a scale Standard Deviation 1.803

PRIMARY outcome

Timeframe: Baseline, Day 29

Population: ITT population included all participants who were randomized and received study drug.

ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=44 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	4.47 units on a scale Standard Deviation 3.185	5.07 units on a scale Standard Deviation 2.214	5.06 units on a scale Standard Deviation 2.361	5.81 units on a scale Standard Deviation 1.714

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.

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.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.

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.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is 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 to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	6 Participants	11 Participants	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Number of Participants With Treatment-Emergent Adverse Events By Severity Severe	0 Participants	0 Participants	—	—
Number of Participants With Treatment-Emergent Adverse Events By Severity Mild	6 Participants	9 Participants	—	—
Number of Participants With Treatment-Emergent Adverse Events By Severity Moderate	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.

Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Number of Participants With Local Tolerability Symptoms	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22, 29

Population: ITT population included all participants who were randomized and received study drug.

ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.

Outcome measures

Measure	AN2728 Ointment 0.5 Percent, Once Daily n=44 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Once Daily n=44 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 2 Percent, Twice Daily n=42 Participants AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Erythema: Baseline	2.23 units on a scale Standard Deviation 0.314	2.14 units on a scale Standard Deviation 0.272	2.12 units on a scale Standard Deviation 0.216	2.15 units on a scale Standard Deviation 0.259
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Erythema: Improvement at Day 8	0.75 units on a scale Standard Deviation 0.678	0.90 units on a scale Standard Deviation 0.596	0.93 units on a scale Standard Deviation 0.620	1.10 units on a scale Standard Deviation 0.637
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Excoriation: Baseline	1.43 units on a scale Standard Deviation 0.818	1.41 units on a scale Standard Deviation 0.851	1.50 units on a scale Standard Deviation 0.819	1.50 units on a scale Standard Deviation 0.819
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Erythema: Improvement at Day 15	1.06 units on a scale Standard Deviation 0.787	1.14 units on a scale Standard Deviation 0.702	1.13 units on a scale Standard Deviation 0.716	1.36 units on a scale Standard Deviation 0.647
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Erythema: Improvement at Day 22	1.02 units on a scale Standard Deviation 0.835	1.17 units on a scale Standard Deviation 0.690	1.11 units on a scale Standard Deviation 0.610	1.40 units on a scale Standard Deviation 0.627
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Erythema: Improvement at Day 29	1.17 units on a scale Standard Deviation 0.785	1.17 units on a scale Standard Deviation 0.646	1.26 units on a scale Standard Deviation 0.718	1.44 units on a scale Standard Deviation 0.636
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Excoriation: Improvement at Day 8	0.49 units on a scale Standard Deviation 0.832	0.74 units on a scale Standard Deviation 0.633	0.88 units on a scale Standard Deviation 0.739	1.02 units on a scale Standard Deviation 0.724
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Excoriation: Improvement at Day 15	0.82 units on a scale Standard Deviation 0.778	0.78 units on a scale Standard Deviation 0.831	0.86 units on a scale Standard Deviation 0.710	1.06 units on a scale Standard Deviation 0.790
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Excoriation: Improvement at Day 22	0.68 units on a scale Standard Deviation 0.922	0.88 units on a scale Standard Deviation 0.897	0.95 units on a scale Standard Deviation 0.731	1.08 units on a scale Standard Deviation 0.803
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Excoriation: Improvement at Day 29	0.82 units on a scale Standard Deviation 0.934	1.03 units on a scale Standard Deviation 0.824	0.96 units on a scale Standard Deviation 0.727	1.17 units on a scale Standard Deviation 0.687
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Exudation: Baseline	0.77 units on a scale Standard Deviation 0.694	0.75 units on a scale Standard Deviation 0.703	0.75 units on a scale Standard Deviation 0.751	0.80 units on a scale Standard Deviation 0.773
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Exudation: Improvement at Day 8	0.31 units on a scale Standard Deviation 0.531	0.49 units on a scale Standard Deviation 0.586	0.48 units on a scale Standard Deviation 0.643	0.61 units on a scale Standard Deviation 0.668
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Exudation: Improvement at Day 15	0.40 units on a scale Standard Deviation 0.782	0.51 units on a scale Standard Deviation 0.796	0.42 units on a scale Standard Deviation 0.732	0.54 units on a scale Standard Deviation 0.657
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Exudation: Improvement at Day 22	0.40 units on a scale Standard Deviation 0.825	0.49 units on a scale Standard Deviation 0.818	0.38 units on a scale Standard Deviation 0.688	0.57 units on a scale Standard Deviation 0.630
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Exudation: Improvement at Day 29	0.40 units on a scale Standard Deviation 0.839	0.57 units on a scale Standard Deviation 0.752	0.42 units on a scale Standard Deviation 0.706	0.64 units on a scale Standard Deviation 0.710
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Lichenification: Baseline	1.67 units on a scale Standard Deviation 0.715	1.58 units on a scale Standard Deviation 0.777	1.60 units on a scale Standard Deviation 0.692	1.58 units on a scale Standard Deviation 0.723
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Lichenification: Improvement at Day 8	0.44 units on a scale Standard Deviation 0.508	0.45 units on a scale Standard Deviation 0.480	0.65 units on a scale Standard Deviation 0.535	0.60 units on a scale Standard Deviation 0.544
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Lichenification: Improvement at Day 15	0.64 units on a scale Standard Deviation 0.554	0.59 units on a scale Standard Deviation 0.622	0.70 units on a scale Standard Deviation 0.644	0.80 units on a scale Standard Deviation 0.681
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Lichenification: Improvement at Day 22	0.55 units on a scale Standard Deviation 0.627	0.63 units on a scale Standard Deviation 0.630	0.71 units on a scale Standard Deviation 0.554	0.77 units on a scale Standard Deviation 0.646
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Lichenification: Improvement at Day 29	0.74 units on a scale Standard Deviation 0.651	0.73 units on a scale Standard Deviation 0.686	0.79 units on a scale Standard Deviation 0.750	0.86 units on a scale Standard Deviation 0.701
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Pruritus: Baseline	2.13 units on a scale Standard Deviation 0.582	2.15 units on a scale Standard Deviation 0.625	2.17 units on a scale Standard Deviation 0.537	2.17 units on a scale Standard Deviation 0.502
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Pruritus: Improvement at Day 8	0.82 units on a scale Standard Deviation 0.941	1.05 units on a scale Standard Deviation 0.855	1.39 units on a scale Standard Deviation 0.753	1.50 units on a scale Standard Deviation 0.812
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Pruritus: Improvement at Day 15	1.11 units on a scale Standard Deviation 0.982	1.32 units on a scale Standard Deviation 0.857	1.40 units on a scale Standard Deviation 0.835	1.62 units on a scale Standard Deviation 0.810
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Pruritus: Improvement at Day 22	1.23 units on a scale Standard Deviation 1.026	1.39 units on a scale Standard Deviation 0.862	1.55 units on a scale Standard Deviation 0.832	1.67 units on a scale Standard Deviation 0.770
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 Pruritus: Improvement at Day 29	1.35 units on a scale Standard Deviation 1.108	1.57 units on a scale Standard Deviation 0.962	1.63 units on a scale Standard Deviation 0.699	1.71 units on a scale Standard Deviation 0.616

Adverse Events

AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily n=44 participants at risk AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily n=42 participants at risk AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
General disorders Application site pain	4.5% 2/44 • Number of events 2	0.00% 0/42
General disorders Application site pruritus	2.3% 1/44 • Number of events 1	2.4% 1/42 • Number of events 1
General disorders Pain	2.3% 1/44 • Number of events 1	0.00% 0/42
Infections and infestations Cellulitis	0.00% 0/44	2.4% 1/42 • Number of events 1
Infections and infestations Nasopharyngitis	2.3% 1/44 • Number of events 1	4.8% 2/42 • Number of events 2
Infections and infestations Tonsillitis	0.00% 0/44	2.4% 1/42 • Number of events 1
Infections and infestations Upper respiratory tract infection	0.00% 0/44	2.4% 1/42 • Number of events 1
Infections and infestations Urinary tract infection	0.00% 0/44	2.4% 1/42 • Number of events 1
Infections and infestations Viral upper respiratory tract infection	2.3% 1/44 • Number of events 1	2.4% 1/42 • Number of events 1
Injury, poisoning and procedural complications Thermal burn	0.00% 0/44	2.4% 1/42 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/44	2.4% 1/42 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.3% 1/44 • Number of events 1	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Asthma	2.3% 1/44 • Number of events 1	0.00% 0/42
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/44	2.4% 1/42 • Number of events 1
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/44	2.4% 1/42 • Number of events 1

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 001-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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