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

NCT ID: NCT04477187

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-12-22

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.

Conditions

Skin Laxity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Group

All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.

Group Type: EXPERIMENTAL

Dermal Handpiece

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey M. Kenkel

Professor and Chair Department of Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Kenkel, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

UT Southwestern Medical Center- Dept of Plastic Surgery

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU-2020-0593

Identifier Type: -

Identifier Source: org_study_id