- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04477187
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern Medical Center- Dept of Plastic Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Group
All subjects will undergo a single treatment for skin laxity in the submentum with a 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Month 3 and Month 6 Follow Up
|
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. |
Month 3 and Month 6 Follow Up
|
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. |
Month 3 and Month 6 Follow Up
|
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. |
Month 3 and Month 6 Follow Up
|
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. |
Month 3 and Month 6 Follow Up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Assessments: Global Aesthetic Improvement Score
Time Frame: Baseline - 6 Months (Day 180)
|
Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)
|
Baseline - 6 Months (Day 180)
|
Subjects Assessment of Pain: Numerical Pain Rating Scale
Time Frame: Visit 2 (Day 0- immediately after study procedure)
|
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)
|
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
|
Skin texture and laxity will be assessed using non invasive skin measurements. Biox Aquaflux- will be used to measure transepidermal water loss. |
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)
|
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. |
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)
|
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. |
Baseline, 3 months, 6 Months (Day 180)
|
Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity)
Time Frame: Baseline, Month 3, Month 6
|
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. |
Baseline, Month 3, Month 6
|
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Time Frame: Baseline, Month 3, Month 6
|
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. |
Baseline, Month 3, Month 6
|
Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness)
Time Frame: Baseline, Month 3, Month 6
|
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. |
Baseline, Month 3, Month 6
|
Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption)
Time Frame: Baseline, Month 3, Month 6
|
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 |
Baseline, Month 3, Month 6
|
Change in Gene Expression at Month 3
Time Frame: Baseline, 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.
|
Baseline, Month 3
|
Change in Gene Expression at Month 6
Time Frame: Baseline, 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.
|
Baseline, Month 6
|
Change in Histology at Month 3
Time Frame: Baseline, 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. |
Baseline, Month 3
|
Change in Histology at Month 6
Time Frame: Baseline, 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. |
Baseline, Month 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeffrey Kenkel, MD, UT Southwestern
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2020-0593
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Laxity
-
Rocky Mountain Biosystems, Inc.CompletedLaxity of SkinUnited States
-
Rocky Mountain Biosystems, Inc.CompletedLaxity of SkinUnited States
-
Merz North America, Inc.Ulthera, IncCompletedMild to Moderate Skin Laxity Under the Chin | Mild to Moderate Skin Laxity on NeckUnited States
-
Apsara Medical CorporationCompleted
-
Ulthera, IncCompletedSkin Laxity of the décolletéUnited States
-
Ulthera, IncUniversity of Texas Southwestern Medical CenterCompletedMild to Moderate Skin Laxity on Cheek | Mild to Moderate Skin Laxity on Upper Neck | Mild to Moderate Subcutaneous Fat on Cheek | Mild to Moderate Subcutaneous Fat on Upper Neck
-
Derming SRLCompletedFace Skin LaxityItaly
-
Nashville Centre for Laser and Facial SurgeryBausch HealthUnknownFacial Skin Laxity
-
Ulthera, IncCompletedFacial Skin LaxityUnited States
-
Endo PharmaceuticalsCompletedLaxity; Skin | Cellulite | Edematous Fibrosclerotic PanniculopathyUnited States
Clinical Trials on Dermal Handpiece
-
Candela CorporationWithdrawn
-
Cataract and Laser Institute of Southern OregonSengiRecruitingCataractUnited States
-
Cynosure, Inc.Completed
-
Candela CorporationCompletedBenign Pigmented Lesions | Facial WrinklesUnited States
-
Centre hospitalier de l'Université de Montréal...RecruitingCataract | Astigmatism | Corneal Endothelial Cell LossCanada
-
Lumenis Be Ltd.Completed
-
Lumenis Be Ltd.Emek Medical CenterRecruitingPigmented Lesions | Vascular LesionIsrael
-
Syneron MedicalCompleted
-
Lumenis Be Ltd.CompletedPigmented Lesions | Vascular LesionUnited States
-
Apyx MedicalActive, not recruiting