A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of the study is to determine whether the topical application of BRT-FC-83C is effective in the treatment of mild to moderate atopic dermatitis.

Detailed Description
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Atopic dermatitis is a common skin disease. BRT-FC-83C is a skin cream that does not contain corticosteroids or other anti-inflammatory components. It represents a novel class of skin barrier repair therapy for chronic dermatoses. The objective of this clinical study is to determine whether BRT-FC-83C, applied twice a day to the affected area of the skin, ameliorates signs and symptoms of mild to moderate atopic dermatitis.

Official Title
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A Clinical Usage Study to Evaluate the Safety and Efficacy of BRT-FC-83C in the Management of Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: BRT-FC-83C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically verified mild to moderate atopic dermatitis. Atopy diagnosis based on clinical scores of 3-7.5 based on the Rajka and Langeland criteria Men or women ages 18-50 years At least one mild to moderate atopic lesion involving no more than 20% Body Surface Area (BSA) Active atopic dermatitis for at least 3 years Willingness to cooperate and participate by following study requirements Written informed consent Exclusion Criteria: Individuals with actively oozing atopic lesions Individuals who are smokers Individuals with insulin-dependent diabetes mellitus Individuals that are known to be pregnant, nursing, or planning to become pregnant within the next six months after enrollment Individuals currently participating in another clinical usage study that would interfere with this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BRT-FC-83C|BRT-FC-83C is a topical cream to treat atopic dermatitis. It is applied topically, twice a day, to the atopic dermatitis skin lesion for six weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site |  | Eight weeks | 
| Change in mean corneometer measurement in lesional skin at target site |  | Eight weeks | 
| Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis |  | Eight weeks | 
| Change in Investigator's Global Assessment (IGA) in lesional skin at target site |  | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy