Clinical trial NCT04477187: Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
Official title: Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline of Soft Tissue Surface Area
timeFrame: Month 3 and Month 6 Follow Up
measure: Percent Change From Baseline in Volume
timeFrame: Month 3 and Month 6 Follow Up
measure: Percent Change in Minor Tissue Strain
timeFrame: Month 3 and Month 6 Follow Up
measure: Percent Change in Horizontal Displacement
timeFrame: Month 3 and Month 6 Follow Up
measure: Percent Change in Vertical Displacement
timeFrame: Month 3 and Month 6 Follow Up
Secondary outcomes:
measure: Improvement in Assessments: Global Aesthetic Improvement Score
timeFrame: Baseline - 6 Months (Day 180)
measure: Subjects Assessment of Pain: Numerical Pain Rating Scale
timeFrame: Visit 2 (Day 0- immediately after study procedure)
measure: Non-invasive Measurements: Transepidermal Water Loss Measurements
timeFrame: Baseline, 3 Month and 6 Month Follow Up
measure: Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz]
timeFrame: Baseline, 3 months, 6 Months (Day 180)
measure: Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient
timeFrame: Baseline, 3 months, 6 Months (Day 180)
measure: Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity)
timeFrame: Baseline, Month 3, Month 6
measure: Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
timeFrame: Baseline, Month 3, Month 6
measure: Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness)
timeFrame: Baseline, Month 3, Month 6
measure: Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption)
timeFrame: Baseline, Month 3, Month 6
measure: Change in Gene Expression at Month 3
timeFrame: Baseline, Month 3
measure: Change in Gene Expression at Month 6
timeFrame: Baseline, Month 6
measure: Change in Histology at Month 3
timeFrame: Baseline, Month 3
measure: Change in Histology at Month 6
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center- Dept of Plastic Surgery
state: Texas
Study officials:
affiliation: UT Southwestern
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: