Atopic Dermatitis
Conditions
Keywords
Efficacy
Brief summary
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
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.
Interventions
DEVICEBRT-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.
Sponsors
Biomed Research & Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site | Eight weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed