AgingNCT05085730

Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments

A study testing InMode Morpheus8 System in people with Aging, 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

This study intends to evaluate the safety and effectiveness of the InMode Morpheus8 System to treat facial and neck skin and assess its effect on skin quality and dermal lines. This device has been FDA cleared for full body subdermal adipose tissue remodeling. Read more about this study

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Aging
What is being tested?: InMode Morpheus8 System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2022to 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.
Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure.
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.
Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness 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).
5 on the Lemperle Wrinkle Assessment Scale or 4 on the Allergan Fine Line Scale and/or Allergan Skin Roughness Scales

Show all 28Show fewer

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

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Clinical Assessment of Skin Quality and Efficacy of Dermal Line Improvement Following Four Bipolar Radiofrequency Microneedling Treatments

Read the detailed description

The primary objective of this study is to evaluate the safety and efficacy of a bipolar fractional radiofrequency treatment via use of the InMode Morpheus8 System to achieve skin texture and quality change and to treat facial fine lines and wrinkles of the lower face.

Conditions: Aging
Being tested: InMode Morpheus8 System
Keywords: skin aging, bipolar radiofrequency, microneedling, dermal lines

What participants receive

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

InMode Morpheus8 SystemDevice
The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.

Study groups in NCT05085730
Study group	Role	What they receive
Treatment	Experimental	All subjects will receive 4 separate treatments with the InMode Morpheus8 System. Receives: Device: InMode Morpheus8 System

What is being measured

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

Change of Fine Lines and Wrinkles
Lemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions.
0- No wrinkles
1. Just perceptible wrinkles
2. Shallow wrinkles
3. Moderately thick wrinkles
4. Deep wrinkles, well defined edges
5. Very deep wrinkles, redundant folds
Lower value would indicate improvement.
Measured: Baseline, 3 Months and 6 Months
Change of Fine Lines
Allergan Scale for Fine Lines- fine lines of the midface/cheeks will be assessed according to the scales definition.
0- None
1. Minimal (1-2 superficial lines)
2. Moderate (3-5 superficial lines)
3. Severe (<5 superficial lines; no crosshatching)
4. Diffuse (diffuse superficial lines; crosshatching)
Lower value would indicate improvement
Measured: Baseline, 3 Months and 6 Months
Change of Skin Roughness
Allergan Skin Roughness Scale Assessment- roughness will be assessed according to the scaled definitions based on skin coarseness, crosshatching and elastosis in midface area.
0- None (smooth visual skin texture)
1. Minimal (slightly course and uneven visual skin texture)
2. Moderate (Moderately coarse and uneven visual skin texture; early elastosis)
3. Severe (severe coarse visual skin texture, crosshatching lines; some elastosis)
4. Diffuse (extreme coarse visual skin texture, deep crosshatched creases; extreme elastosis)
Lower value would indicate improvement
Measured: Baseline, 3 Months and 6 Months
Global Aesthetic Improvement Scale (GAIS)
Scale will be used to assess aesthetic change
1. Very much improved
2. Much improved
3. Improved
4. No Change
5. Worse
Lower value would indicate improvement
Measured: 3 Months and 6 Months

Secondary outcomes (9)

Adverse Events
Adverse events will be monitored at each visit
Measured: Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6
Change in Exploratory Thickness/Density- High Resolution Ultrasound
high resolution ultrasound will be utilized to assess skin thickness/density.
Measured: Baseline, 3 Months and 6 Months
Change in Barrier Skin Function- TEWL
Transepidermal Water Loss Measurements (TEWL measurements) (via Bio Aquaflux) will be used to evaluate barrier function of the skin epidermal layer after treatments. It is used to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. Skin barrier dysfunction results in increased TEWL.
Measured: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Laxity, Elasticity)
Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum.
Measured: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum.
Measured: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Stiffness)
Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum.
Measured: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Energy Absorption)
Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum.
Measured: Baseline, 3 Months and 6 Months
Change in Gene Expression
Gene expression assessments will be completed to analyze protein related to collagen, elastin, and the extracellular matrix production. Gene Expression studies cellular activity and Collagen 1, Collagen 3, Elastin, LOX, IL8 and MMP2 are all biomarkers. Gene expression was only compared between baseline and 6 months.
Fold changes were compared to control from Ct values of RT-qPCR reactions.
- Ct: threshold cycle
- RT-qPCR: Quantitative reverse transcription polymerase chain reaction)
Measured: Baseline and 6 Months
Change in Histology Assessments
Histological assessments (microscopic study-tissue structure, elastin, collagen and hyaluronic acid expression) will be completed after taking biopsies ( from the cheek adjacent to the nasolabial fold within the designated area for treatment) of the skin area to correlate changes to the skin after treatments. Histology studies the structure of the tissue. Collagen 3, Collagen 1, Elastin, Macrophage are biomarkers. Histology was only compared between baseline and 6 months.
Fold changes compared to control were calculated from fluorescence intensity of a confocal microscopy images.
Measured: Baseline and 6 Months

Timeline

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

14 Jan 202222 Dec 2022

First posted20 Oct 2021
Study start14 Jan 2022
Primary completion22 Dec 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 AgingStudies 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: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05085730
Sponsor's protocol ID: STU 2021-0916
Status last verified: Oct 2023
First submitted: 27 Sep 2021
Last updated: 31 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of Skin Quality and Efficacy of Dermal Line Improvement Following Four Bipolar Radiofrequency Microneedling Treatments
ClinicalTrials.gov ID: NCT05085730
Acronym / sponsor ID: STU 2021-0916
Conditions: Aging
Keywords: skin aging, bipolar radiofrequency, microneedling, dermal lines
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: 14 Jan 2022 (actual)
Primary completion: 22 Dec 2022 (actual)
Study completion: 22 Dec 2022 (actual)
First posted: 20 Oct 2021 (actual)
Results: Posted 10 Oct 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
Treatment	Experimental	Device: InMode Morpheus8 SystemAll subjects will receive 4 separate treatments with the InMode Morpheus8 System.

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.
Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure.
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
InMode Morpheus8 SystemThe InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.	Device	Treatment

Primary outcome

Change of Fine Lines and Wrinkles
Time frame: Baseline, 3 Months and 6 Months
Lemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions. 0- No wrinkles 1. Just perceptible wrinkles 2. Shallow wrinkles 3. Moderately thick wrinkles 4. Deep wrinkles, well defined edges 5. Very deep wrinkles, redundant folds Lower value would indicate improvement.
Change of Fine Lines
Time frame: Baseline, 3 Months and 6 Months
Allergan Scale for Fine Lines- fine lines of the midface/cheeks will be assessed according to the scales definition. 0- None 1. Minimal (1-2 superficial lines) 2. Moderate (3-5 superficial lines) 3. Severe (<5 superficial lines; no crosshatching) 4. Diffuse (diffuse superficial lines; crosshatching) Lower value would indicate improvement
Change of Skin Roughness
Time frame: Baseline, 3 Months and 6 Months
Allergan Skin Roughness Scale Assessment- roughness will be assessed according to the scaled definitions based on skin coarseness, crosshatching and elastosis in midface area. 0- None (smooth visual skin texture) 1. Minimal (slightly course and uneven visual skin texture) 2. Moderate (Moderately coarse and uneven visual skin texture; early elastosis) 3. Severe (severe coarse visual skin texture, crosshatching lines; some elastosis) 4. Diffuse (extreme coarse visual skin texture, deep crosshatched creases; extreme elastosis) Lower value would indicate improvement
Global Aesthetic Improvement Scale (GAIS)
Time frame: 3 Months and 6 Months
Scale will be used to assess aesthetic change 1. Very much improved 2. Much improved 3. Improved 4. No Change 5. Worse Lower value would indicate improvement

9 secondary outcomes

Adverse Events
Time frame: Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6
Change in Exploratory Thickness/Density- High Resolution Ultrasound
Time frame: Baseline, 3 Months and 6 Months
Change in Barrier Skin Function- TEWL
Time frame: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Laxity, Elasticity)
Time frame: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Time frame: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Stiffness)
Time frame: Baseline, 3 Months and 6 Months
Biomechanical Tissue Measurements (Energy Absorption)
Time frame: Baseline, 3 Months and 6 Months
Change in Gene Expression
Time frame: Baseline and 6 Months
Change in Histology Assessments
Time frame: Baseline and 6 Months

Results and safety

Results posted to the registry on 10 Oct 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
Treatment	13	8

Primary outcome: Change of Fine Lines and Wrinkles

Time frame: Baseline, 3 Months and 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Baseline n = 8	Month 3 n = 8	Month 6 n = 8
Nasolabial Fold	1.25 (0.71)	1.625 (1.06)	1 (0.93)
Upper Lip Lines	1.56 (0.50)	1.75 (0.89)	1.125 (0.64)
Corner of Mouth Lines	2.13 (1.36)	1.5 (1.20)	1.25 (1.04)
Marionette Lines	1.25 (1.39)	1.31 (1.03)	1.06 (1.08)
Lower Lip Line	1.06 (0.56)	1.25 (0.89)	0.5 (0.53)

Primary outcome: Change of Fine Lines

Time frame: Baseline, 3 Months and 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Baseline n = 8	Month 3 n = 8	Month 6 n = 8
Value	1.625 (0.518)	2 (0.532)	1.375 (0.916)

Primary outcome: Change of Skin Roughness

Time frame: Baseline, 3 Months and 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Baseline n = 8	Month 3 n = 8	Month 6 n = 8
Value	1.25 (0.71)	0.5 (0.76)	0.38 (0.75)

Primary outcome: Global Aesthetic Improvement Scale (GAIS)

Time frame: 3 Months and 6 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	Month 3 n = 8	Month 6 n = 8
Clinician GAIS (Live Assessment)	3.81 (0.84)	2.38 (1.06)
Subject GAIS (Live Assessment)	2.88 (0.99)	2.63 (1.06)
Clinician GAS (Photo Assessment)	3.81 (0.55)	3.25 (0.57)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected in a 6 month period after first treatment was completed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	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 31 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Jeffrey Kenkel, MD principal investigator

UT Southwestern- Department of Plastic Surgery

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

Questions about this trial

What is this clinical trial studying?

A study testing InMode Morpheus8 System in people with Aging, 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 31 Oct 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 10 Oct 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?

Change of Fine Lines and Wrinkles (time frame: Baseline, 3 Months and 6 Months). The study lists 4 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 NCT05085730.

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 31 Oct 2023.