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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883311
• Other study ID #: BRT-C09-C017
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2009
• Last updated: August 29, 2010
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2010
• Source: Biomed Research & Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas J. Stephens & Associates, Inc.	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Biomed Research & Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site		Eight weeks	No
Secondary	Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site		Eight weeks	No
Secondary	Change in mean corneometer measurement in lesional skin at target site		Eight weeks	No
Secondary	Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis		Eight weeks	No
Secondary	Change in Investigator's Global Assessment (IGA) in lesional skin at target site		Eight weeks	No