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

NCT ID: NCT00883311

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Keywords

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Efficacy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomed Research & Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Thomas J. Stephens & Associates, Inc.

Principal Investigators

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Nathan S. Trookman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Thomas J. Stephens & Associates, Inc.

Locations

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Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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BRT-C09-C017

Identifier Type: -

Identifier Source: org_study_id