Wrinkles and RhytidesNCT01701440
Efficacy Study for Magnetic Induction to Treat Wrinkles
A study testing Biofusionary Bebe in people with Wrinkles and Rhytides, run by Rocky Mountain Biosystems, Inc. at 1 site in United States.
Trial summary
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles and Rhytides
- What is being tested?
- Biofusionary Bebe
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2013
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The exclusion criteria for the study are:
- History of skin hypersensitivity,
- Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
- Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
- Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
- The current or recent use (within the past 12 months) of isotretinoin,
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- Pregnancy,
- Infectious diseases (such as HIV) present,
- Are a tobacco smoker,
- Insulin dependent diabetic subjects,
- Oxygen dependent subjects,
- Subjects with severe chronic illness, scleroderma, or lupus,
- Subjects with open sores or scars in the treatment region, or
- Subjects with ischemia in the treatment region.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Laser and Dermatolgy Institute of Chicago,LLC
Chicago, Illinois, 60611
About this study
Official title: Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.
- Conditions
- Wrinkles and Rhytides
- Being tested
- Biofusionary Bebe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofusionary BebeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cosmesis
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared
Measured: 1 month
Secondary outcomes (1)
Improvement in cosmesis
Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles and RhytidesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome Garden, MD, Principal investigator, Physicians Laser and Dermatology Institute of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701440
- Sponsor's protocol ID
- 0310-0017
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
- ClinicalTrials.gov ID
- NCT01701440
- Acronym / sponsor ID
- 0310-0017
- Conditions
- Wrinkles and Rhytides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rocky Mountain Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 5 Oct 2012 (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.
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- History of skin hypersensitivity,
- Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
- Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
- Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
- The current or recent use (within the past 12 months) of isotretinoin,
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 |
|---|---|---|
| Biofusionary Bebe | Device | – |
Primary outcome
Improvement in cosmesis
Time frame: 1 month
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared
1 secondary outcome
Improvement in cosmesis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
Jerome Garden, MD principal investigator
Physicians Laser and Dermatology Institute of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofusionary Bebe in people with Wrinkles and Rhytides, run by Rocky Mountain Biosystems, 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 0 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Oct 2012. 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.
Are results available for this study?
Results are not available in the source record.
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?
Improvement in cosmesis (time frame: 1 month). 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 11 Oct 2012.