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Completed

NCT Number: NCT00883311

A Study of BRT-FC-83C for the Treatment of 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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site

    Time frame: Eight weeks

Secondary outcomes

  1. Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site

    Time frame: Eight weeks

  2. Change in mean corneometer measurement in lesional skin at target site

    Time frame: Eight weeks

  3. Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis

    Time frame: Eight weeks

  4. Change in Investigator's Global Assessment (IGA) in lesional skin at target site

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

Biomed Research & Technologies, Inc.

Industry

Registry information

Official study title

A Clinical Usage Study to Evaluate the Safety and Efficacy of BRT-FC-83C in the Management of Mild to Moderate Atopic Dermatitis

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 17, 2009
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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