Skin LaxityNCT04477187

Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling

A study testing Dermal Handpiece in people with Skin Laxity, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue. Read more about this study

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Skin Laxity
What is being tested?: Dermal Handpiece
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2020to 22 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Healthy male and female adults between ages 21-70 years of age.
Desire skin laxity lift of the submental region.
Confirmed BMI ≤ 35.
Subjects who can read, understand, and sign the Informed Consent Form.
Subjects willing and able to comply with all study requirements.
Fitzpatrick skin type I-VI.
Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental Fat Rating Scale
Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.

Who cannot join

Active localized or systemic infections, that may alter wound healing.
Immunocompromised subjects.
Subjects with coagulation disorder.
History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4, Appendix E), or other anatomical feature for which reduction in SMF which may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.

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Scarring in areas to be treated.
Tattoos in the treatment areas to be treated.
Significant open facial wounds or lesions.
Severe or cystic acne in treatment areas.
Current active smoker.
Use of Accutane (Isotretinoin) within the past 6 months.
Use of topical retinoids within 48 hours.
Use of prescription anticoagulants.
Pacemaker or internal defibrillator.
History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin).
Subjects on current oral corticosteroid therapy or within the past 6 months
Metal implants in the treatment area.
In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
Subjects with a history of radiation therapy to the treatment area.
Subject has a history of allergy to lidocaine or ester-based local anesthetics.
Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine.
Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation).
Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator.
Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year.
Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area.
Subjects have undergone laser and light treatments in the treatment area over the past 3 months.
Subjects have undergone superficial peel or microdermabrasion within 4 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center- Dept of Plastic Surgery
Dallas, Texas, 75390

Other trials in United States

About this study

Read the detailed description

This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a total of up to 15 qualified and consenting subjects to receive one bipolar fractional radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic Surgery.

Conditions: Skin Laxity
Being tested: Dermal Handpiece
Medical subject headings: Cutis Laxa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dermal HandpieceDevice
Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.

Study groups in NCT04477187
Study group	Role	What they receive
Single Group	Experimental	All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Receives: Device: Dermal Handpiece

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline of Soft Tissue Surface Area
3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements.
Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Measured: Month 3 and Month 6 Follow Up
Percent Change From Baseline in Volume
3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements.
Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Measured: Month 3 and Month 6 Follow Up
Percent Change in Minor Tissue Strain
Percent change in Minor Tissue Strain is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements.
Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Measured: Month 3 and Month 6 Follow Up
Percent Change in Horizontal Displacement
Percent change in Horizontal Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements.
Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Measured: Month 3 and Month 6 Follow Up
Percent Change in Vertical Displacement
Percent change in Vertical Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements.
Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Measured: Month 3 and Month 6 Follow Up

Secondary outcomes (13)

Improvement in Assessments: Global Aesthetic Improvement Score
Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)
Measured: Baseline - 6 Months (Day 180)
Subjects Assessment of Pain: Numerical Pain Rating Scale
Immediately after the study procedure, subjects will be asked to rate any pain or discomfort using a 11-point Numerical Pain Rating Scale (0= No pain, 10= Extreme pain)
Measured: Visit 2 (Day 0- immediately after study procedure)
Non-invasive Measurements: Transepidermal Water Loss Measurements
Skin texture and laxity will be assessed using non invasive skin measurements.
Biox Aquaflux- will be used to measure transepidermal water loss.
Measured: Baseline, 3 Month and 6 Month Follow Up
Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz]
Skin texture and laxity will be assessed using non invasive skin measurements. Skin laxity and elasticity are measured using the Biomechanical Tissue Characterization System.
Optical coherence tomography (OCT) will be used to topographical and histological images of pre- and post-treated skin.
Ra, is the average measurement of skin curvatures and takes into all account variances in the skin roughness profile from the center line.
Rz, is the difference between the highest and lowest data points from the mean surface measurement.
Measured: Baseline, 3 months, 6 Months (Day 180)
Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient
Skin texture and laxity will be assessed using non invasive skin measurements.
Optical coherence tomography (OCT) will be used to topographical and histological images of pre- and post-treated skin.
Attenuation coefficient (AC) is a measure of the decay of light intensity within the sample due to absorption and scattering.
Measured: Baseline, 3 months, 6 Months (Day 180)
Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity)
Skin laxity and elasticity will be assessed using non invasive skin measurements.
Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin laxity, elasticity.
Measured: Baseline, Month 3, Month 6
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Skin Elastic, Viscoelastic and Ultimate Deformation will be assessed using non invasive skin measurements.
Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin Elastic, Viscoelastic and Ultimate Deformation.
Measured: Baseline, Month 3, Month 6
Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness)
Skin stiffness will be assessed using non invasive skin measurements.
Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin stiffness.
Measured: Baseline, Month 3, Month 6
Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption)
Energy absorption will be assessed using non invasive skin measurements.
Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin - Energy absorption
Measured: Baseline, Month 3, Month 6
Change in Gene Expression at Month 3
Biopsies collected from subjects will be analyzed to observe changes from baseline to Month 3. Gene Expression studies cellular activity and Col1, Col3, ELN, Lox, IL8 are all biomarkers.
Fold Changes were compared to control and calculated from Ct values of RT-qPCR reactions.
- Ct: threshold cycle
- RT-qPCR: Quantitative reverse transcription polymerase chain reaction)
Measured: Baseline, Month 3
Change in Gene Expression at Month 6
Biopsies collected from subjects will be analyzed to observe changes from baseline to Month 6 . Gene Expression studies cellular activity and Col1, Col3, ELN, Lox, IL8 are all biomarkers.
Fold Changes were compared to control and calculated from Ct values of RT-qPCR reactions.
- Ct: threshold cycle
- RT-qPCR: Quantitative reverse transcription polymerase chain reaction)
Measured: Baseline, Month 6
Change in Histology at Month 3
All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.
Dermal Handpiece: Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
Fold changes were compared to control and were calculated from fluorescence intensity of a confocal microscopy images.
Histology studies the structure of the tissue. Col3, Col1, ELN, Macrophage are biomarkers.
Measured: Baseline, Month 3
Change in Histology at Month 6
All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.
Dermal Handpiece: Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
Histology studies the structure of the tissue. Col3, Col1, ELN, Macrophage are biomarkers.
Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202022 Dec 2022

First posted20 Jul 2020
Study start1 Oct 2020
Primary completion13 Jun 2022
Study completion22 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin LaxityStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04477187
Sponsor's protocol ID: STU-2020-0593
Status last verified: Nov 2023
First submitted: 8 Jul 2020
Last updated: 19 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Skin Laxity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
ClinicalTrials.gov ID: NCT04477187
Acronym / sponsor ID: STU-2020-0593
Conditions: Skin Laxity
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 13 Jun 2022 (actual)
Study completion: 22 Dec 2022 (actual)
First posted: 20 Jul 2020 (actual)
Results: Posted 19 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Group	Experimental	Device: Dermal HandpieceAll subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy male and female adults between ages 21-70 years of age.
Desire skin laxity lift of the submental region.
Confirmed BMI ≤ 35.
Subjects who can read, understand, and sign the Informed Consent Form.
Subjects willing and able to comply with all study requirements.

Key exclusion criteria (28 listed)

Active localized or systemic infections, that may alter wound healing.
Immunocompromised subjects.
Subjects with coagulation disorder.
History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).

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
Dermal HandpieceRadiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.	Device	Single Group

Primary outcome

Percent Change From Baseline of Soft Tissue Surface Area
Time frame: Month 3 and Month 6 Follow Up
3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Percent Change From Baseline in Volume
Time frame: Month 3 and Month 6 Follow Up
3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Percent Change in Minor Tissue Strain
Time frame: Month 3 and Month 6 Follow Up
Percent change in Minor Tissue Strain is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Percent Change in Horizontal Displacement
Time frame: Month 3 and Month 6 Follow Up
Percent change in Horizontal Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.
Percent Change in Vertical Displacement
Time frame: Month 3 and Month 6 Follow Up
Percent change in Vertical Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

13 secondary outcomes

Improvement in Assessments: Global Aesthetic Improvement Score
Time frame: Baseline - 6 Months (Day 180)
Subjects Assessment of Pain: Numerical Pain Rating Scale
Time frame: Visit 2 (Day 0- immediately after study procedure)
Non-invasive Measurements: Transepidermal Water Loss Measurements
Time frame: Baseline, 3 Month and 6 Month Follow Up
Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz]
Time frame: Baseline, 3 months, 6 Months (Day 180)
Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient
Time frame: Baseline, 3 months, 6 Months (Day 180)
Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity)
Time frame: Baseline, Month 3, Month 6
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Time frame: Baseline, Month 3, Month 6
Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness)
Time frame: Baseline, Month 3, Month 6
Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption)
Time frame: Baseline, Month 3, Month 6
Change in Gene Expression at Month 3
Time frame: Baseline, Month 3
Change in Gene Expression at Month 6
Time frame: Baseline, Month 6
Change in Histology at Month 3
Time frame: Baseline, Month 3
Change in Histology at Month 6
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 19 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Group	15	13

Primary outcome: Percent Change From Baseline of Soft Tissue Surface Area

Time frame: Month 3 and Month 6 Follow Up. Mean (Standard Deviation). Unit: percent change

Measure	Month 3 Follow Up n = 15	6 Month Follow Up n = 13
Value	-0.18 (0.89)	-017 (0.32)

Population analysed: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

Primary outcome: Percent Change From Baseline in Volume

Time frame: Month 3 and Month 6 Follow Up. Mean (Standard Deviation). Unit: percent change

Measure	Month 3 Follow Up n = 15	6 Month Follow Up n = 13
Value	-1.30 (0.68)	-1.9 (1.8)

Population analysed: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

Primary outcome: Percent Change in Minor Tissue Strain

Time frame: Month 3 and Month 6 Follow Up. Mean (Standard Deviation). Unit: percentage change

Measure	Month 3 Follow Up n = 15	6 Month Follow Up n = 13
Value	-5.0 (2.5)	-0.44 (0.53)

Population analysed: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

Primary outcome: Percent Change in Horizontal Displacement

Time frame: Month 3 and Month 6 Follow Up. Mean (Standard Deviation). Unit: percent change

Measure	Month 3 Follow Up n = 15	6 Month Follow Up n = 13
Value	-0.55 (0.99)	-0.44 (0.53)

Population analysed: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Group	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Skin Laxity

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
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Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
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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.

Jeffrey Kenkel, MD principal investigator

UT Southwestern

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dermal Handpiece in people with Skin Laxity, run by University of Texas Southwestern Medical Center 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 28 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 19 Dec 2023. 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?

Yes. Results are posted in the registry (first posted 19 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline of Soft Tissue Surface Area (time frame: Month 3 and Month 6 Follow Up). The study lists 5 primary outcomes in all. 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 NCT04477187.

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 19 Dec 2023.