Skin Tightening of the Mandibular and Sub-mandibular AreasNCT01813747
Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece
A study testing 1440 nm wavelength laser with handpiece (Cynosure) in people with Skin Tightening of the Mandibular and Sub-mandibular Areas, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Tightening of the Mandibular and Sub-mandibular Areas
- What is being tested?
- 1440 nm wavelength laser with handpiece (Cynosure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy non-smoking male or female subjects 18-65 years of age
- Presents for treatment of their unwanted skin laxity and fat in the mandibular and submandibular areas for an improved aesthetic appearance and is willing to undergo laser treatment
- Understands/accepts obligation not to receive any other procedures in the mid-face to sub-mandibular areas through 3 months follow up visit
- Understands/accepts the obligation and is logistically able to present for all scheduled follow up visits
- Is capable of understanding the consent form and able to provide written consent to participate in the study and any other practice consents for anesthesia and surgical procedures
- Understands/accepts obligation to have facial photographs taken
- Understands/accepts may be asked to consent to having a two 2mm biopsies in an inconspicuous place such as behind the ear
- Agrees to maintain present diet and exercise program
Who cannot join
- Has had any procedure in the mid-face to sub-mandibular areas in the last six months
- Has a history of thrombophlebitis, history of coagulation disorders or using anticoagulant medications
- Has a significant systemic illness or immunity disorder or localized condition affecting treatment area
- Is female and pregnant, was pregnant or given birth within the last three months, is currently breast feeding, or planning a pregnancy during the course of the study
- Has known history of allergic reactions to local anesthesia
- Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study
Show all 10Show fewer
- Is susceptible to light induced seizures or history of seizures
- Has a history of keloid formation
- Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity
- Has a BMI above 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetique - Dermatology, Laser & Plastic Surgery LLP
Greenvale, New York, 11548
About this study
The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis.
- Being tested
- 1440 nm wavelength laser with handpiece (Cynosure)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1440 nm wavelength laser with handpiece (Cynosure)Device
To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.
| Study group | Role | What they receive |
|---|---|---|
| 1440 nm wavelength laser with hand piece | Experimental | To assess the effectiveness of the 1440 nm wavelength laser with handpiece for skin tightening and laser lipolysis for the mandibular and sub-mandibular areas Receives: Device: 1440 nm wavelength laser with handpiece (Cynosure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation
Photos will be evaluated by the investigator comparing time baseline and 3 month photos using the global aesthetic improvement scale
Measured: 3 months post last treatment
Photographic Evaluation
Photographs will be evaluated and compared by investigator for baseline and 3 month images using the Cervicomental Angle Scale
Measured: 3 months post last treatment
Secondary outcomes (3)
Number of participants with adverse events
Side effects and events will be recorded
Measured: up to 3 months post last treatment
Photographic Evaluation
Photos will be evaluated by the investigator comparing time baseline and 1 week photos using the global aesthetic improvement scale
Measured: 1 week post treatment
Photographic Evaluation
Photographs will be evaluated and compared by investigator for baseline and 1 week images using the Cervicomental Angle Scale
Measured: 1 week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Tightening of the Mandibular and Sub-mandibular AreasStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Even though this study has recruited slightly more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Krantz, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813747
- Sponsor's protocol ID
- CYN10-DS-MS2
- Status last verified
- Oct 2020
- First submitted
- 12 Mar 2013
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece
- ClinicalTrials.gov ID
- NCT01813747
- Acronym / sponsor ID
- CYN10-DS-MS2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Mar 2013 (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 study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Even though this study has recruited slightly more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
| Arm | Type | Receives |
|---|---|---|
| 1440 nm wavelength laser with hand piece | Experimental | Device: 1440 nm wavelength laser with handpiece (Cynosure)To assess the effectiveness of the 1440 nm wavelength laser with handpiece for skin tightening and laser lipolysis for the mandibular and sub-mandibular areas |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy non-smoking male or female subjects 18-65 years of age
- Presents for treatment of their unwanted skin laxity and fat in the mandibular and submandibular areas for an improved aesthetic appearance and is willing to undergo laser treatment
- Understands/accepts obligation not to receive any other procedures in the mid-face to sub-mandibular areas through 3 months follow up visit
- Understands/accepts the obligation and is logistically able to present for all scheduled follow up visits
- Is capable of understanding the consent form and able to provide written consent to participate in the study and any other practice consents for anesthesia and surgical procedures
Key exclusion criteria (10 listed)
- Has had any procedure in the mid-face to sub-mandibular areas in the last six months
- Has a history of thrombophlebitis, history of coagulation disorders or using anticoagulant medications
- Has a significant systemic illness or immunity disorder or localized condition affecting treatment area
- Is female and pregnant, was pregnant or given birth within the last three months, is currently breast feeding, or planning a pregnancy during the course of the study
- Has known history of allergic reactions to local anesthesia
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 |
|---|---|---|
| 1440 nm wavelength laser with handpiece (Cynosure)To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas. | Device | 1440 nm wavelength laser with hand piece |
Primary outcome
Photographic Evaluation
Time frame: 3 months post last treatment
Photos will be evaluated by the investigator comparing time baseline and 3 month photos using the global aesthetic improvement scale
Photographic Evaluation
Time frame: 3 months post last treatment
Photographs will be evaluated and compared by investigator for baseline and 3 month images using the Cervicomental Angle Scale
3 secondary outcomes
Number of participants with adverse events
Time frame: up to 3 months post last treatment
Photographic Evaluation
Time frame: 1 week post treatment
Photographic Evaluation
Time frame: 1 week post treatment
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 27 Oct 2020.
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.
Patricia Krantz study director
Cynosure, 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 1440 nm wavelength laser with handpiece (Cynosure) in people with Skin Tightening of the Mandibular and Sub-mandibular Areas, run by Cynosure, 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 8 inclusion and 10 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 27 Oct 2020. 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?
Photographic Evaluation (time frame: 3 months post last treatment). The study lists 2 primary outcomes in all. 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 27 Oct 2020.