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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: AN2728 Topical Ointment, 2% QD
* Drug: AN2728 Topical Ointment, 0.5% QD
* Drug: AN2728 Topical Ointment, 2% BID
* Drug: AN2728 Topical Ointment, 0.5% BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AN2728 Topical Ointment, 2% QD vs 0.5% QD<br>AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion Treatments will be randomly assigned to target lesions A and B. | Drug: AN2728 Topical Ointment, 2% QD<br>* AN2728 Topical Ointment, 2% QD<br>Drug: AN2728 Topical Ointment, 0.5% QD<br>* AN2728 Topical Ointment, 0.5% QD<br>|
| Experimental: AN2728 Topical Ointment, 2% BID vs 0.5% BID<br>AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion. Treatments will be randomly assigned to target lesions A and B. | Drug: AN2728 Topical Ointment, 2% BID<br>* AN2728 Topical Ointment, 2% BID<br>Drug: AN2728 Topical Ointment, 0.5% BID<br>* AN2728 Topical Ointment, 0.5% BID<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 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. | Baseline up to Day 29 | 
| 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. | Baseline up to Day 29 | 
| 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 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. | Baseline up to Day 29 | 
| Number of Participants With Treatment-Emergent Adverse Events By Severity | 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. | Baseline up to Day 29 | 
| Number of Participants With Local Tolerability Symptoms | Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure. | Baseline up to Day 29 | 
| 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. | Baseline, Day 8, 15, 22, 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis