Laxity of SkinNCT01279226
Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides
A study testing Auralevée device 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 intended to be used to 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laxity of Skin
- What is being tested?
- Auralevée device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at least 21 years old,
- Apparently healthy,
- Informed consent signed by the subject.
Who cannot join
- Tobacco smokers,
- History of skin hypersensitivity,
- Current skin disorder or infection (e.g., herpes simplex),
- Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
- Subjects with a 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,
- 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 Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to 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 device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auralevée deviceDevice
Single treatment with Auralevée device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved cosmesis
Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.
Measured: 2-6 timepoints from 4 days to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Cooperrider, MD, Principal investigator, Laser Treatment CenterStephen Flock, PhD, Study director, Rocky Mountain Biosystems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279226
- Sponsor's protocol ID
- 0310-0002A
- Status last verified
- Oct 2012
- First submitted
- 14 Jan 2011
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 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
- NCT01279226
- Acronym / sponsor ID
- 0310-0002A
- Conditions
- Laxity of Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rocky Mountain Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 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 intended to be used to 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
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female at least 21 years old,
- Apparently healthy,
- Informed consent signed by the subject.
Key exclusion criteria (13 listed)
- Tobacco smokers,
- History of skin hypersensitivity,
- Current skin disorder or infection (e.g., herpes simplex),
- Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
- Subjects with a 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 deviceSingle treatment with Auralevée device. | Device | – |
Primary outcome
Improved cosmesis
Time frame: 2-6 timepoints from 4 days to 6 months
Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.
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 3 Dec 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.
Peter Cooperrider, MD principal investigator
Laser Treatment Center
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 device 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 3 inclusion and 13 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 3 Dec 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?
Improved cosmesis (time frame: 2-6 timepoints from 4 days to 6 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 3 Dec 2012.