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

A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01602341

Enrollment

Registered

2012-05-21

Start date

2012-08-31

Completion date

2013-01-31

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis

Brief summary

The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)

Interventions

DRUGAN2728 Topical Ointment, 2% QD

AN2728 Topical Ointment, 2% QD

DRUGAN2728 Topical Ointment, 0.5% QD

AN2728 Topical Ointment, 0.5% QD

DRUGAN2728 Topical Ointment, 2% BID

AN2728 Topical Ointment, 2% BID

DRUGAN2728 Topical Ointment, 0.5% BID

AN2728 Topical Ointment, 0.5% BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Male or female 12 to 17 years of age, inclusive * Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka) * Total body surface area (BSA) of atopic dermatitis involvement ≤35% * Presence of two comparable target lesions * Willing and able to comply with study instructions and commit to attending all visits * Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study. * Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion criteria

* Significant confounding conditions as assessed by study doctor * Unstable or actively infected AD * Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation * History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis) * Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period * Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years * Current pregnancy or lactation, or intent to become pregnant during the study * Known sensitivity to any of the components of the study drug * Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * Participated in a previous AN2728 clinical study

Design outcomes

Primary

Measure	Time frame	Description
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Baseline, Day 8	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.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	Baseline, Day 15	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.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	Baseline, Day 22	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.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	Baseline, Day 29	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.

Secondary

Measure	Time frame	Description
Number of Participants With Local Tolerability Symptoms	Baseline up to Day 29	Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Baseline up to Day 29	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.
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Baseline, Day 8, 15, 22, 29	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.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities	Baseline up to Day 29	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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to Day 29	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.
Number of Participants With Treatment-Emergent Adverse Events By Severity	Baseline up to Day 29	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.

Countries

Australia, United States

Participant flow

Participants by arm

Arm	Count
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 AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.	44
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.	42
Total	86

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1

Baseline characteristics

Characteristic	AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily	AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily	Total
Age, Categorical <=18 years	44 Participants	42 Participants	86 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Gender Female	29 Participants	23 Participants	52 Participants
Gender Male	15 Participants	19 Participants	34 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 44	11 / 42
serious Total, serious adverse events	0 / 44	0 / 42

Outcome results

Primary

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15

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.

Time frame: Baseline, Day 15

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

Arm	Measure	Value (MEAN)	Dispersion
AN2728 Ointment 0.5 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	4.02 units on a scale	Standard Deviation 2.781
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	4.34 units on a scale	Standard Deviation 2.394
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	4.51 units on a scale	Standard Deviation 2.4
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15	5.36 units on a scale	Standard Deviation 2.028

Primary

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22

Time frame: Baseline, Day 22

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

Arm	Measure	Value (MEAN)	Dispersion
AN2728 Ointment 0.5 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	3.86 units on a scale	Standard Deviation 3.157
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	4.55 units on a scale	Standard Deviation 2.551
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	4.70 units on a scale	Standard Deviation 2.271
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22	5.49 units on a scale	Standard Deviation 1.803

Primary

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29

Time frame: Baseline, Day 29

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

Arm	Measure	Value (MEAN)	Dispersion
AN2728 Ointment 0.5 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	4.47 units on a scale	Standard Deviation 3.185
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	5.07 units on a scale	Standard Deviation 2.214
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	5.06 units on a scale	Standard Deviation 2.361
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29	5.81 units on a scale	Standard Deviation 1.714

Primary

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8

Time frame: Baseline, Day 8

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

Arm	Measure	Group	Value (MEAN)	Dispersion
AN2728 Ointment 0.5 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Baseline	8.22 units on a scale	Standard Deviation 1.891
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Improvement at Day 8	3.63 units on a scale	Standard Deviation 1.695
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Baseline	8.02 units on a scale	Standard Deviation 1.852
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Baseline	8.13 units on a scale	Standard Deviation 1.811
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Improvement at Day 8	4.33 units on a scale	Standard Deviation 2.208
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Baseline	8.19 units on a scale	Standard Deviation 1.811
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8	Improvement at Day 8	4.81 units on a scale	Standard Deviation 1.972

Secondary

Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29

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.

Time frame: Baseline, Day 8, 15, 22, 29

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

Arm	Measure	Group	Value (MEAN)	Dispersion
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 0.5 Percent, Once Daily	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
AN2728 Ointment 2 Percent, Once Daily	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	0.51 units on a scale	Standard Deviation 0.796
AN2728 Ointment 2 Percent, Once Daily	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	0.63 units on a scale	Standard Deviation 0.63
AN2728 Ointment 2 Percent, Once Daily	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	0.49 units on a scale	Standard Deviation 0.818
AN2728 Ointment 2 Percent, Once Daily	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	0.57 units on a scale	Standard Deviation 0.752
AN2728 Ointment 2 Percent, Once Daily	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	0.59 units on a scale	Standard Deviation 0.622
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Lichenification: Baseline	1.58 units on a scale	Standard Deviation 0.777
AN2728 Ointment 2 Percent, Once Daily	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	0.45 units on a scale	Standard Deviation 0.48
AN2728 Ointment 2 Percent, Once Daily	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 0.646
AN2728 Ointment 2 Percent, Once Daily	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	0.90 units on a scale	Standard Deviation 0.596
AN2728 Ointment 2 Percent, Once Daily	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	1.32 units on a scale	Standard Deviation 0.857
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Excoriation: Baseline	1.41 units on a scale	Standard Deviation 0.851
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Erythema: Baseline	2.14 units on a scale	Standard Deviation 0.272
AN2728 Ointment 2 Percent, Once Daily	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	0.74 units on a scale	Standard Deviation 0.633
AN2728 Ointment 2 Percent, Once Daily	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	1.05 units on a scale	Standard Deviation 0.855
AN2728 Ointment 2 Percent, Once Daily	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	0.78 units on a scale	Standard Deviation 0.831
AN2728 Ointment 2 Percent, Once Daily	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	0.88 units on a scale	Standard Deviation 0.897
AN2728 Ointment 2 Percent, Once Daily	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	1.14 units on a scale	Standard Deviation 0.702
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Pruritus: Baseline	2.15 units on a scale	Standard Deviation 0.625
AN2728 Ointment 2 Percent, Once Daily	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	1.03 units on a scale	Standard Deviation 0.824
AN2728 Ointment 2 Percent, Once Daily	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	1.57 units on a scale	Standard Deviation 0.962
AN2728 Ointment 2 Percent, Once Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Exudation: Baseline	0.75 units on a scale	Standard Deviation 0.703
AN2728 Ointment 2 Percent, Once Daily	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	1.39 units on a scale	Standard Deviation 0.862
AN2728 Ointment 2 Percent, Once Daily	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	0.73 units on a scale	Standard Deviation 0.686
AN2728 Ointment 2 Percent, Once Daily	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	0.49 units on a scale	Standard Deviation 0.586
AN2728 Ointment 2 Percent, Once Daily	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	1.17 units on a scale	Standard Deviation 0.69
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Lichenification: Baseline	1.60 units on a scale	Standard Deviation 0.692
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Erythema: Baseline	2.12 units on a scale	Standard Deviation 0.216
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.93 units on a scale	Standard Deviation 0.62
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.13 units on a scale	Standard Deviation 0.716
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.11 units on a scale	Standard Deviation 0.61
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.26 units on a scale	Standard Deviation 0.718
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Excoriation: Baseline	1.50 units on a scale	Standard Deviation 0.819
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.88 units on a scale	Standard Deviation 0.739
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.86 units on a scale	Standard Deviation 0.71
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.95 units on a scale	Standard Deviation 0.731
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.96 units on a scale	Standard Deviation 0.727
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Exudation: Baseline	0.75 units on a scale	Standard Deviation 0.751
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.48 units on a scale	Standard Deviation 0.643
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.42 units on a scale	Standard Deviation 0.732
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.38 units on a scale	Standard Deviation 0.688
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.42 units on a scale	Standard Deviation 0.706
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.65 units on a scale	Standard Deviation 0.535
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.70 units on a scale	Standard Deviation 0.644
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.71 units on a scale	Standard Deviation 0.554
AN2728 Ointment 0.5 Percent, Twice Daily	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	0.79 units on a scale	Standard Deviation 0.75
AN2728 Ointment 0.5 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Pruritus: Baseline	2.17 units on a scale	Standard Deviation 0.537
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.39 units on a scale	Standard Deviation 0.753
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.40 units on a scale	Standard Deviation 0.835
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.55 units on a scale	Standard Deviation 0.832
AN2728 Ointment 0.5 Percent, Twice Daily	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	1.63 units on a scale	Standard Deviation 0.699
AN2728 Ointment 2 Percent, Twice Daily	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	0.77 units on a scale	Standard Deviation 0.646
AN2728 Ointment 2 Percent, Twice Daily	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	0.61 units on a scale	Standard Deviation 0.668
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Exudation: Baseline	0.80 units on a scale	Standard Deviation 0.773
AN2728 Ointment 2 Percent, Twice Daily	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	1.71 units on a scale	Standard Deviation 0.616
AN2728 Ointment 2 Percent, Twice Daily	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	0.86 units on a scale	Standard Deviation 0.701
AN2728 Ointment 2 Percent, Twice Daily	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	1.17 units on a scale	Standard Deviation 0.687
AN2728 Ointment 2 Percent, Twice Daily	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	1.08 units on a scale	Standard Deviation 0.803
AN2728 Ointment 2 Percent, Twice Daily	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	1.67 units on a scale	Standard Deviation 0.77
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Pruritus: Baseline	2.17 units on a scale	Standard Deviation 0.502
AN2728 Ointment 2 Percent, Twice Daily	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	1.06 units on a scale	Standard Deviation 0.79
AN2728 Ointment 2 Percent, Twice Daily	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	1.02 units on a scale	Standard Deviation 0.724
AN2728 Ointment 2 Percent, Twice Daily	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	1.10 units on a scale	Standard Deviation 0.637
AN2728 Ointment 2 Percent, Twice Daily	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	1.50 units on a scale	Standard Deviation 0.812
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Excoriation: Baseline	1.50 units on a scale	Standard Deviation 0.819
AN2728 Ointment 2 Percent, Twice Daily	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	1.44 units on a scale	Standard Deviation 0.636
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Erythema: Baseline	2.15 units on a scale	Standard Deviation 0.259
AN2728 Ointment 2 Percent, Twice Daily	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	1.62 units on a scale	Standard Deviation 0.81
AN2728 Ointment 2 Percent, Twice Daily	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	0.60 units on a scale	Standard Deviation 0.544
AN2728 Ointment 2 Percent, Twice Daily	Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29	Lichenification: Baseline	1.58 units on a scale	Standard Deviation 0.723
AN2728 Ointment 2 Percent, Twice Daily	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	0.64 units on a scale	Standard Deviation 0.71
AN2728 Ointment 2 Percent, Twice Daily	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	1.40 units on a scale	Standard Deviation 0.627
AN2728 Ointment 2 Percent, Twice Daily	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	0.80 units on a scale	Standard Deviation 0.681
AN2728 Ointment 2 Percent, Twice Daily	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	0.57 units on a scale	Standard Deviation 0.63
AN2728 Ointment 2 Percent, Twice Daily	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	0.54 units on a scale	Standard Deviation 0.657
AN2728 Ointment 2 Percent, Twice Daily	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	1.36 units on a scale	Standard Deviation 0.647

Secondary

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

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.

Time frame: Baseline up to Day 29