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
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedAugust 31, 2010
August 1, 2010
6 months
April 15, 2009
August 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
Eight weeks
Secondary Outcomes (4)
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
Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis
Eight weeks
Change in Investigator's Global Assessment (IGA) in lesional skin at target site
Eight weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, 80915, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan S. Trookman, M.D.
Thomas J. Stephens & Associates, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2009
First Posted
April 17, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
August 31, 2010
Record last verified: 2010-08