NCT05085730

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

Completed NA Results posted Last updated 31 October 2023

What this trial tests

NA trial testing InMode Morpheus8 System in Aging in 13 participants. Completed in 22 December 2022.

Timeline

14 January 2022

Primary endpoint
22 December 2022

22 December 2022

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	14 January 2022
Primary completion	22 December 2022
Estimated completion	22 December 2022
Sites	1 location across United States

Drugs / interventions tested

• InMode Morpheus8 System

Conditions studied

• Aging — all drugs for Aging →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 21 to 70, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change of Fine Lines and Wrinkles Primary · 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.

Nasolabial Fold

Group	Value	95% CI
Baseline	1.25	± 0.71
Month 3	1.625	± 1.06
Month 6	1	± 0.93

Upper Lip Lines

Group	Value	95% CI
Baseline	1.56	± 0.50
Month 3	1.75	± 0.89
Month 6	1.125	± 0.64

Corner of Mouth Lines

Group	Value	95% CI
Baseline	2.13	± 1.36
Month 3	1.5	± 1.20
Month 6	1.25	± 1.04

Marionette Lines

Group	Value	95% CI
Baseline	1.25	± 1.39
Month 3	1.31	± 1.03
Month 6	1.06	± 1.08

Lower Lip Line

Group	Value	95% CI
Baseline	1.06	± 0.56
Month 3	1.25	± 0.89
Month 6	0.5	± 0.53

Change of Fine Lines Primary · 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

Group	Value	95% CI
Baseline	1.625	± 0.518
Month 3	2	± 0.532
Month 6	1.375	± 0.916

Change of Skin Roughness Primary · 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

Group	Value	95% CI
Baseline	1.25	± 0.71
Month 3	0.5	± 0.76
Month 6	0.38	± 0.75

Global Aesthetic Improvement Scale (GAIS) Primary · 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

Clinician GAIS (Live Assessment)

Group	Value	95% CI
Month 3	3.81	± 0.84
Month 6	2.38	± 1.06

Subject GAIS (Live Assessment)

Group	Value	95% CI
Month 3	2.88	± 0.99
Month 6	2.63	± 1.06

Clinician GAS (Photo Assessment)

Group	Value	95% CI
Month 3	3.81	± 0.55
Month 6	3.25	± 0.57

Adverse Events Secondary · Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6

Adverse events will be monitored at each visit

Group	Value	95% CI
Treatment	0

Change in Exploratory Thickness/Density- High Resolution Ultrasound Secondary · Baseline, 3 Months and 6 Months

high resolution ultrasound will be utilized to assess skin thickness/density.

Epidermal Thickness

Group	Value	95% CI
Baseline	72	± 7.07
Month 3	82.67	± 15.02
Month 6	73	± 8.90

Epidermal Density

Group	Value	95% CI
Baseline	69.53	± 11.02
Month 3	73.30	± 38.51
Month 6	79.65	± 19.43

Dermal Thickness

Group	Value	95% CI
Baseline	1257.33	± 351.80
Month 3	1214.83	± 186.151
Month 6	1311.33	± 175.08

Dermal Density

Group	Value	95% CI
Baseline	10.94	± 4.88
Month 3	17.18	± 11.54
Month 6	21.32	± 9.66

Change in Barrier Skin Function- TEWL Secondary · Baseline, 3 Months and 6 Months

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.

Group	Value	95% CI
Baseline	26.16	± 4.97
Month 3	22.51	± 6.87
Month 6	18.08	± 2.81

Biomechanical Tissue Measurements (Laxity, Elasticity) Secondary · Baseline, 3 Months and 6 Months

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.

Laxity

Group	Value	95% CI
Baseline	1.05	± 0.40
Month 3	0.66	± 0.33
Month 6	0.89	± 0.29

Elasticity

Group	Value	95% CI
Baseline	0.69	± 0.24
Month 3	0.54	± 0.22
Month 6	0.54	± 0.23

Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) Secondary · Baseline, 3 Months and 6 Months

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.

Elastic Deformation

Group	Value	95% CI
Baseline	1.57	± 0.43
Month 3	1.1	± 0.36
Month 6	1.23	± 0.31

Viscoelastic Deformation

Group	Value	95% CI
Baseline	0.10	± 0.03
Month 3	0.07	± 0.02
Month 6	0.07	± 0.02

Ultimate Deformation

Group	Value	95% CI
Baseline	1.66	± 0.45
Month 3	1.17	± 0.36
Month 6	1.34	± 0.32

Biomechanical Tissue Measurements (Stiffness) Secondary · Baseline, 3 Months and 6 Months

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.

Group	Value	95% CI
Baseline	189.52	± 41.19
Month 3	225.82	± 66.99
Month 6	226.44	± 44.07

Biomechanical Tissue Measurements (Energy Absorption) Secondary · Baseline, 3 Months and 6 Months

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.

Group	Value	95% CI
Baseline	74.32	± 17.30
Month 3	59.69	± 15.78
Month 6	61.04	± 14.22

Change in Gene Expression Secondary · Baseline and 6 Months

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)

Collagen 1

Group	Value	95% CI
Month 6	1.16	± 0.28

Collagen 3

Group	Value	95% CI
Month 6	0.62	± 0.42

Elastin

Group	Value	95% CI
Month 6	1.72	± 0.63

LOX

Group	Value	95% CI
Month 6	1.06	± 0.71

IL8

Group	Value	95% CI
Month 6	0.24	± 0.18

MMP2

Group	Value	95% CI
Month 6	2.78	± 1.98

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148