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

Biomed Research & Technologies

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Device: BRT-FC-83C

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883311

BRT-C09-C017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)