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
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 March 13, 2014
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases