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

Phase 2

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT00883311
• Lead Sponsor: Biomed Research & Technologies, Inc.

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-17
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-08
• Disposition First Submitted: 2010-08-26
• Disposition First Submitted QC: 2010-08-26
• Last Update Submitted: 2010-08-29
• Disposition First Posted: 2010-08-30
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site	Eight weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Thomas J. Stephens & Associates, Inc.; 🇺🇸 Colorado Springs, Colorado, United States