A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
This study has been completed.
Information provided by:
Biomed Research & Technologies, Inc.
First received: April 15, 2009
Last updated: August 29, 2010
Last verified: August 2010
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Clinical Usage Study to Evaluate the Safety and Efficacy of BRT-FC-83C in the Management of Mild to Moderate Atopic Dermatitis
Primary Outcome Measures:
- Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
- Change in mean corneometer measurement in lesional skin at target site [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
- Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
- Change in Investigator's Global Assessment (IGA) in lesional skin at target site [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2009 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883311
|Thomas J. Stephens & Associates, Inc.
|Colorado Springs, Colorado, United States, 80915 |
Biomed Research & Technologies, Inc.
||Nathan S. Trookman, M.D.
||Thomas J. Stephens & Associates, Inc.
No publications provided
||Nathan S. Trookman, M.D./Principal Investigator, Thomas J. Stephens & Associates, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 15, 2009
||August 29, 2010
||United States: Institutional Review Board
Keywords provided by Biomed Research & Technologies, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases