Atopic DermatitisPhase 2NCT00883311
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
A Phase 2 study testing BRT-FC-83C in people with Atopic Dermatitis, run by Biomed Research & Technologies, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BRT-FC-83C
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, 80915
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- BRT-FC-83C
- Keywords
- Efficacy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRT-FC-83CDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
Measured: Eight weeks
Secondary outcomes (4)
Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site
Measured: Eight weeks
Change in mean corneometer measurement in lesional skin at target site
Measured: Eight weeks
Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis
Measured: Eight weeks
Change in Investigator's Global Assessment (IGA) in lesional skin at target site
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomed Research & Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathan S. Trookman, M.D., Principal investigator, Thomas J. Stephens & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883311
- Sponsor's protocol ID
- BRT-C09-C017
- Status last verified
- Aug 2010
- First submitted
- 15 Apr 2009
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00883311
- Acronym / sponsor ID
- BRT-C09-C017
- Conditions
- Atopic Dermatitis
- Keywords
- Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biomed Research & Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRT-FC-83CBRT-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. | Device | – |
Primary outcome
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
Time frame: Eight weeks
4 secondary outcomes
Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site
Time frame: Eight weeks
Change in mean corneometer measurement in lesional skin at target site
Time frame: Eight weeks
Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis
Time frame: Eight weeks
Change in Investigator's Global Assessment (IGA) in lesional skin at target site
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan S. Trookman, M.D. principal investigator
Thomas J. Stephens & Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BRT-FC-83C in people with Atopic Dermatitis, run by Biomed Research & Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2010.