A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis | NCT00883311

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

NCT00883311

Sponsor

Biomed Research & Technologies, Inc.

Status

Completed

Last Update Posted

Aug 31, 2010Estimated

Enrollment

32Actual

Phase

Phase 2

Conditions

Atopic Dermatitis

Interventions

BRT-FC-83C

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Apr 15, 2009

First Submission Date that Met QC Criteria

Apr 15, 2009

First Posted Date

Apr 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 26, 2010

Certification/Extension First Submitted that Passed QC Review

Aug 26, 2010

Certification/Extension First Posted Date

Aug 30, 2010Estimated

Last Update Submitted Date

Aug 29, 2010

Last Update Posted Date

Aug 31, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BRT-FC-83C	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site		Eight weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site		Eight weeks
Change in mean corneometer measurement in lesional skin at target site		Eight weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathan S. Trookman, M.D.	Thomas J. Stephens & Associates, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas J. Stephens & Associates, Inc.		Colorado Springs	Colorado	80915	United States

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided