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

August 29, 2010 updated by: Biomed Research & Technologies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Atopic Dermatitis

Intervention / Treatment

Device: BRT-FC-83C

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Colorado Springs, Colorado, United States, 80915
    - Thomas J. Stephens & Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomed Research & Technologies, Inc.

Investigators

Principal Investigator: Nathan S. Trookman, M.D., Thomas J. Stephens & Associates, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)