Skin WrinklingNCT04606368
Bausch Health Thermage FXL for Use on Lower Face and Submentum Area
A study testing Thermage FLX in people with Skin Wrinkling, run by Lorraine Hickson at 1 site in United States.
Trial summary
This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Wrinkling
- What is being tested?
- Thermage FLX
- 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
- 29 Sep 2020to 2 Apr 2021
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects > 40 years of age and < 80 years of age.
- Presence of mild to moderate skin laxity on lower face and submentum area, which in the investigator's opinion may benefit from monopolar radiofrequency to improve the skin laxity for a youthful, rejuvenated appearance.
- BMI under 35.
- Agreement to maintain their weight within 5 lb of the baseline.
- Subject has read and signed a written informed consent form.
Who cannot join
- Subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
- Subject has had a surgical procedure(s) in the area of intended treatment.
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Currently taking or has taken diet pills or weight control supplements within the past month.
- Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
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- Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- Pregnant or intending to become pregnant in the next 6 months.
- Lactating or has been lactating in the past 6 months.
- BMI ≥ 35.
- Unable or unwilling to comply with the study requirements.
- Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of Sequential Use of Monopolar Radiofrequency Treatment on Lower Face and Submental Area for Fat Reduction and Improvement of Skin Laxity
This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.
Read the detailed description
This research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. This will be measured by conducting a treatment using the Thermage FLX system on the lower face and submentum area of the participants. Biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. Finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.
- Conditions
- Skin Wrinkling
- Being tested
- Thermage FLX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermage FLXDevice
Monopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area.
| Study group | Role | What they receive |
|---|---|---|
| Interventional cohort | Experimental | Each subject will serve as their own control. Left side of lower jaw and submental area is control side. Right side of subject's lower jaw and submentum area will receive treatment. Receives: Device: Thermage FLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
The primary objective of this study is to evaluate the safety and efficacy of improvement of skin laxity with the use of monopolar radiofrequency (Thermage FLX, Solta Medical) on lower face and submentum areas. Safety is defined as incidence of device- and/or procedure-related adverse events. Qualitative measurement of efficacy by independent blinded evaluators grading randomized baseline and 3 months follow-up photographs using a 4-point skin laxity rating scale.
Measured: 12 weeks
Secondary outcomes (2)
Subjective clinical evaluation of skin laxity with the use of monopolar radiofrequency treatment on lower face and neck [Efficacy]
Quantitative measurement of efficacy by standardized 2-D and 3-D images with volume difference in cc, height difference in mm, and surface area reduction measures calculations in cm2 using VECTRA H2 (Canfield Scientific, Inc), as well as, by histochemistry evaluation of punch biopsies performed at baseline, 4 weeks and 12 weeks post-procedure.
Measured: up to 12 weeks
Subject satisfaction of skin laxity treatment on lower face and submentum areas documented in written questionnaire
Subject satisfaction data will be collected at the 12-week final follow-up visit via a written questionnaire. A validated questionnaire using a likert rating scale will be utilized . Score values are 1 to 5, with high numbers meaning better outcomes.
Measured: though study completion, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start29 Sep 2020
- Primary completion17 Mar 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WrinklingStudies 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
- Model description
- Prospective, single-center, non-randomized, interventional cohort study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lorraine Hickson
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc., Solta Medical
- Responsible party
- Sponsor-investigator, Lorraine Hickson, Riverchase Dermatology
- Investigators
- Leyda R Bowes, MD, Principal investigator, Riverchase Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606368
- Sponsor's protocol ID
- Bausch Health 2019-4816
- Status last verified
- Sep 2021
- First submitted
- 12 Oct 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Sequential Use of Monopolar Radiofrequency Treatment on Lower Face and Submental Area for Fat Reduction and Improvement of Skin Laxity
- ClinicalTrials.gov ID
- NCT04606368
- Acronym / sponsor ID
- Bausch Health 2019-4816
- Conditions
- Skin Wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lorraine HicksonUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc., Solta Medical
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 28 Oct 2020 (actual)
- 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.
This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.
Detailed description
This research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. This will be measured by conducting a treatment using the Thermage FLX system on the lower face and submentum area of the participants. Biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. Finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, non-randomized, interventional cohort study
| Arm | Type | Receives |
|---|---|---|
| Interventional cohort | Experimental | Device: Thermage FLXEach subject will serve as their own control. Left side of lower jaw and submental area is control side. Right side of subject's lower jaw and submentum area will receive treatment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects > 40 years of age and < 80 years of age.
- Presence of mild to moderate skin laxity on lower face and submentum area, which in the investigator's opinion may benefit from monopolar radiofrequency to improve the skin laxity for a youthful, rejuvenated appearance.
- BMI under 35.
- Agreement to maintain their weight within 5 lb of the baseline.
- Subject has read and signed a written informed consent form.
Key exclusion criteria (13 listed)
- Subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
- Subject has had a surgical procedure(s) in the area of intended treatment.
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Currently taking or has taken diet pills or weight control supplements within the past month.
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 |
|---|---|---|
| Thermage FLXMonopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area. | Device | Interventional cohort |
Primary outcome
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
Time frame: 12 weeks
The primary objective of this study is to evaluate the safety and efficacy of improvement of skin laxity with the use of monopolar radiofrequency (Thermage FLX, Solta Medical) on lower face and submentum areas. Safety is defined as incidence of device- and/or procedure-related adverse events. Qualitative measurement of efficacy by independent blinded evaluators grading randomized baseline and 3 months follow-up photographs using a 4-point skin laxity rating scale.
2 secondary outcomes
Subjective clinical evaluation of skin laxity with the use of monopolar radiofrequency treatment on lower face and neck [Efficacy]
Time frame: up to 12 weeks
Subject satisfaction of skin laxity treatment on lower face and submentum areas documented in written questionnaire
Time frame: though study completion, up to 12 weeks
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 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Leyda R Bowes, MD principal investigator
Riverchase Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermage FLX in people with Skin Wrinkling, run by Lorraine Hickson 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 5 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 29 Sep 2021. 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?
Incidence of treatment-emergent Adverse Events [Safety and Tolerability] (time frame: 12 weeks). 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 29 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.