Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Official Title
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A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: AN2728 ointment, 2%
* Drug: AN2898 ointment, 1%
* Drug: AN2898 ointment vehicle
* Drug: AN2728 ointment vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin Presence of two (2) comparable target lesions Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study. Exclusion Criteria: Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation Significant confounding conditions as assessed by study doctor History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis) Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: AN2898 ointment, 1%, vs. ointment vehicle<br>AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion. Treatments will be randomly assigned to target lesions A and B. | Drug: AN2898 ointment, 1%<br>* AN2898 ointment, 1%, applied twice daily for 6 weeks<br>Drug: AN2898 ointment vehicle<br>* AN2898 ointment vehicle applied twice daily for 6 weeks<br>|
| Experimental: AN2728 ointment, 2%, vs. ointment vehicle<br>AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion. Treatments will be randomly assigned to target lesions A and B. | Drug: AN2728 ointment, 2%<br>* AN2728 ointment, 2%, applied twice daily for 6 weeks<br>Drug: AN2728 ointment vehicle<br>* AN2728 ointment vehicle applied twice daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) | ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. | Baseline (Day 1) | 
| Atopic Dermatitis Severity Index (ADSI) Score at Day 14 | ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. | Day 14 | 
| Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. | Day 28 | 
| Atopic Dermatitis Severity Index (ADSI) Score at Day 42 | ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. | Day 42 | 
| Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 | ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure. | Baseline (Day 1), Day 28 | 

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