Bipolar RF Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue and Effect on Elastin

NCT04245696 | Withdrawn FDA Device

• 1 other identifier: PFD19002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue

Conditions

Skin Laxity

Keywords

RF; Micro-needling; Submental Skin Laxity

Outcome Measures

Primary Outcomes (2)

• Change in submental skin laxity

  Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 180 (post-procedure) photographs

  Baseline - Day 180 (6 months post-treatment)

• Occurrence, severity, and relatedness of adverse events

  The number and level of severity of adverse events after device treatment. An assessment will also be made to determine if the adverse event is related to the study devices and/or procedure

  Baseline - Day 180 (6 months post-treatment)

Secondary Outcomes (5)

• Change in submental skin laxity

  Baseline - Day 90 (3 months post-treatment)

• Surface Area Assessment to demonstrate percentage of participants having improvement in tissue lift (> 20mm2 in submental and neck skin laxity)

  Baseline vs. Day 180

• Subject assessment of improvement in skin laxity

  3 Month Follow-Up and 6 Month Follow-Up

• Subject satisfaction of treatment results: Subject Satisfaction scale

  Day 14 - 6 Month Follow-Up

• Subject assessment of pain: Numerical Pain Rating Scale

  Treatment Visit

Study Arms (1)

Single Group

EXPERIMENTAL

Single Arm: All subjects will undergo treatment for skin laxity in the submentum with a Dermal and SubQ handpiece

Device: Dermal Handpiece / SubQ Handpiece

Interventions

Dermal Handpiece / SubQ Handpiece DEVICE

Bipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.

Single Group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female adults between ages 21-70 years of age.
• Desire skin laxity lift of submental and neck regions.
• 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 (CR-SMFRS, 0=Absent (No localized submental fat evidence), 4=Extreme (Extreme submental convexity)

You may not qualify if:

• 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=Severe, superficial wrinkling present), or other anatomical feature for which reduction in submental fat (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.

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (1)

Candela Institute of Excellence

Marlborough, Massachusetts, 01752, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Konika Patel Schallen, MD

  Candela Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: March 9, 2020
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

US (1)