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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883311
First Posted: April 17, 2009
Last Update Posted: August 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biomed Research & Technologies, Inc.
April 15, 2009
April 17, 2009
August 31, 2010
January 2009
July 2009   (Final data collection date for primary outcome measure)
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site [ Time Frame: Eight weeks ]
The primary efficacy outcome is the change in mean Atopic Dermatitis Severity Index (ADSI) and Investigator's Global Assessment (IGA) [ Time Frame: Eight weeks ]
Complete list of historical versions of study NCT00883311 on ClinicalTrials.gov Archive Site
  • Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site [ Time Frame: Eight weeks ]
  • Change in mean corneometer measurement in lesional skin at target site [ Time Frame: Eight weeks ]
  • Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis [ Time Frame: Eight weeks ]
  • Change in Investigator's Global Assessment (IGA) in lesional skin at target site [ Time Frame: Eight weeks ]
  • Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site [ Time Frame: Eight weeks ]
  • Change in mean corneometer measurement in lesional skin at target site [ Time Frame: Eight weeks ]
  • Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis [ Time Frame: Eight weeks ]
Not Provided
Not Provided
 
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Atopic Dermatitis
Device: BRT-FC-83C
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00883311
BRT-C09-C017
Yes
Not Provided
Not Provided
Nathan S. Trookman, M.D./Principal Investigator, Thomas J. Stephens & Associates, Inc.
Biomed Research & Technologies, Inc.
Not Provided
Principal Investigator: Nathan S. Trookman, M.D. Thomas J. Stephens & Associates, Inc.
Biomed Research & Technologies, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP