Submental LaxityNCT02595216
Treatment With the Profound System for Submental Laxity
A study testing Profound System in people with Submental Laxity, run by Syneron Medical at 5 sites in United States.
Trial summary
Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a single treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Submental Laxity
- What is being tested?
- Profound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2015to Dec 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects seeking laxity treatment for submental area
- Healthy female or male subjects ages 18 to 70 years of age
- Informed consent process completed and signed consent
- Willing to receive the proposed Profound treatment and follow the protocol
- For female subjects: not pregnant or lactating;
- either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
- Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations
Who cannot join
- Surgery or any other procedure for laxity in the last 6 months
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Known allergy to lidocaine or epinephrine or antibiotics
- Active malignancy or history of malignancy in the past 5 years
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process)
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- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion)
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
- History of significant lymphatic drainage problems
- History of cancer which required lymph node biopsy or dissection
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- History of keloid scarring, abnormal wound healing and / or prone to bruising
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
- Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
- Systemic corticosteroid therapy 6 months prior to and throughout the course of the study
- Dysplastic nevi in the area to be treated
- Participation in a study of another device or drug within 3 month prior to enrollment or during this study, if treatments of wrinkles or laxity were involved
- Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used
- Subjects with history of severe edema
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mark Beaty
Alpharetta, Georgia, 30009
Dr. Richard Gentile
Boardman, Ohio, 44512
Coliseum Health System
Macon, Georgia, 31217
Premier Plastic Surgery
San Mateo, California, 94401
Gladstone Clinic
San Ramon, California, 94583
About this study
Official title: Clinical Study to Evaluate the Performance of Profound System With Nominal Angle of 75° to the Skin's Surface for Submental Laxity
Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a single treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.
Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol.
Read the detailed description
This study is a Prospective clinical study to evaluate the Profound device for submental laxity.
Up to a total of 60 healthy candidates, seeking treatment for submental laxity. Subjects will receive one Profound treatment targeted to both dermal and subcutaneous layer of the skin.
Before treatment (15-20 minutes) the tissue to be treated will be injected with tumescence solution.
Each subject will be followed for additional four (4) post treatment visits
- Conditions
- Submental Laxity
- Being tested
- Profound System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profound SystemDevice
The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity
| Study group | Role | What they receive |
|---|---|---|
| all subjects | Experimental | All subjects in this study will receive a single Profound system treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.
Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol. Receives: Device: Profound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Performance of Profound system to the skin's surface for submental laxity
using Fitzpatrick Wrinkle and Alexiades-Armenakas Laxity Scales
Measured: at 6 months
Secondary outcomes (4)
safety of the profound single treatment by record of the Number, severity and type of adverse events
Number, severity and type of adverse events recorded
Measured: from day 0 until 6 months
Investigator satisfaction
assessed by Investigator
Measured: day 0, 1, 3, and 6 months
Subject Satisfaction
by Subject questionnaire
Measured: 1, 3, and 6 months
Subject pain assessment
using Numerical Scale Response (NSR)
Measured: day 0 (treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Submental LaxityStudies 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
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Beaty, M.D., Principal investigator, Beaty Facial Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595216
- Sponsor's protocol ID
- DHF20161
- Status last verified
- Apr 2017
- First submitted
- 29 Oct 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ruiz-Esparza J. Nonablative radiofrequency for facial and neck rejuvenation. A faster, safer, and less painful procedure based on concentrating the heat in key areas: the ThermaLift concept. J Cosmet Dermatol. 2006 Mar;5(1):68-75. doi: 10.1111/j.1473-2165.2006.00226.x.
PubMed 17173575
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of Profound System With Nominal Angle of 75° to the Skin's Surface for Submental Laxity
- ClinicalTrials.gov ID
- NCT02595216
- Acronym / sponsor ID
- DHF20161
- Conditions
- Submental Laxity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Nov 2015 (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.
Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a single treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.
Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol.
Detailed description
This study is a Prospective clinical study to evaluate the Profound device for submental laxity.
Up to a total of 60 healthy candidates, seeking treatment for submental laxity. Subjects will receive one Profound treatment targeted to both dermal and subcutaneous layer of the skin.
Before treatment (15-20 minutes) the tissue to be treated will be injected with tumescence solution.
Each subject will be followed for additional four (4) post treatment visits
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all subjects | Experimental | Device: Profound SystemAll subjects in this study will receive a single Profound system treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment. Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects seeking laxity treatment for submental area
- Healthy female or male subjects ages 18 to 70 years of age
- Informed consent process completed and signed consent
- Willing to receive the proposed Profound treatment and follow the protocol
- For female subjects: not pregnant or lactating;
Key exclusion criteria (21 listed)
- Surgery or any other procedure for laxity in the last 6 months
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Known allergy to lidocaine or epinephrine or antibiotics
- Active malignancy or history of malignancy in the past 5 years
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
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 |
|---|---|---|
| Profound SystemThe Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity | Device | all subjects |
Primary outcome
Evaluate the Performance of Profound system to the skin's surface for submental laxity
Time frame: at 6 months
using Fitzpatrick Wrinkle and Alexiades-Armenakas Laxity Scales
4 secondary outcomes
safety of the profound single treatment by record of the Number, severity and type of adverse events
Time frame: from day 0 until 6 months
Investigator satisfaction
Time frame: day 0, 1, 3, and 6 months
Subject Satisfaction
Time frame: 1, 3, and 6 months
Subject pain assessment
Time frame: day 0 (treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Background: PubMed 17173575Ruiz-Esparza J. Nonablative radiofrequency for facial and neck rejuvenation. A faster, safer, and less painful procedure based on concentrating the heat in key areas: the ThermaLift concept. J Cosmet Dermatol. 2006 Mar;5(1):68-75. doi: 10.1111/j.1473-2165.2006.00226.x.
- Individual participant dataSharing planned: Undecided
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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.
Mark Beaty, M.D. principal investigator
Beaty Facial Plastic Surgery
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profound System in people with Submental Laxity, run by Syneron Medical at 5 sites 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 7 inclusion and 21 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Evaluate the Performance of Profound system to the skin's surface for submental laxity (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595216, which also lists 1 linked publication.
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 6 Apr 2017.