Back to resultsA Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BRT-FC-83C
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Efficacy
Eligibility Criteria
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
Sites / Locations
- Thomas J. Stephens & Associates, Inc.
Outcomes
Primary Outcome Measures
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
Secondary Outcome Measures
Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site
Change in mean corneometer measurement in lesional skin at target site
Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis
Change in Investigator's Global Assessment (IGA) in lesional skin at target site
Full Information
NCT ID
NCT00883311
First Posted
April 15, 2009
Last Updated
August 29, 2010
Sponsor
Biomed Research & Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00883311
Brief Title
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
Official Title
A Clinical Usage Study to Evaluate the Safety and Efficacy of BRT-FC-83C in the Management of Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biomed Research & Technologies, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
BRT-FC-83C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site
Time Frame
Eight weeks
Title
Change in mean corneometer measurement in lesional skin at target site
Time Frame
Eight weeks
Title
Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis
Time Frame
Eight weeks
Title
Change in Investigator's Global Assessment (IGA) in lesional skin at target site
Time Frame
Eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan S. Trookman, M.D.
Organizational Affiliation
Thomas J. Stephens & Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas J. Stephens & Associates, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
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