Laxity of SkinNCT01273961
Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures
A study testing AuraLevée treatment in people with Laxity of Skin, run by Rocky Mountain Biosystems, Inc. at 1 site in United States.
Trial summary
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity of Skin
- What is being tested?
- AuraLevée treatment
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 21 to 70 years old,
- For females, at least 9 months post-partum,
- Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
- For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
- Apparently healthy,
- Informed consent signed by the subject.
Who cannot join
- History of skin hypersensitivity,
- Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
- Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
- Suffering from hormonal imbalance which may affect weight or cellulite,
- 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,
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- The current or recent use (within the past 12 months) of isotretinoin,
- Pregnancy or breast feeding,
- 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.
About this study
Official title: Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.
- Conditions
- Laxity of Skin
- Being tested
- AuraLevée treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuraLevée treatmentDevice
A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.
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 and 3 months after treatment. Circumference changes will be measured and compared.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity of SkinStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Wolfe, MD, Principal investigator, Center for Cosmetic SurgeryStephen Flock, PhD, Study director, Rocky Mountain Biosystems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273961
- Sponsor's protocol ID
- 0310-0003
- Status last verified
- Feb 2012
- First submitted
- 7 Jan 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring
- ClinicalTrials.gov ID
- NCT01273961
- Acronym / sponsor ID
- 0310-0003
- Conditions
- Laxity of Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rocky Mountain Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Jan 2011 (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 this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 21 to 70 years old,
- For females, at least 9 months post-partum,
- Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
- For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
- Apparently healthy,
Key exclusion criteria (15 listed)
- History of skin hypersensitivity,
- Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
- Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
- Suffering from hormonal imbalance which may affect weight or cellulite,
- Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
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 |
|---|---|---|
| AuraLevée treatmentA single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck. | Device | – |
Primary outcome
Improvement in cosmesis
Time frame: 1 and 3 months
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared.
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 9 Feb 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.
Andrew Wolfe, MD principal investigator
Center for Cosmetic Surgery
Stephen Flock, PhD study director
Rocky Mountain Biosystems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuraLevée treatment in people with Laxity of Skin, 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 6 inclusion and 15 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 9 Feb 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?
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?
Improvement in cosmesis (time frame: 1 and 3 months). 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 9 Feb 2012.