CONFORM: Rotational Fractional Resection for Submental Contouring

The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Study Overview

• Status: Completed
• Conditions: Lipodystrophy; Skin Laxity
• Intervention / Treatment: Device: Rotational fractional resection (1.5mm diameter device)

Detailed Description

This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Aesthetx
    • Newport Beach, California, United States, 92663
      • Steve Yoelin, MD Medical Associates, Inc.
    • Roseville, California, United States, 95661
      • Roseville Facial Plastic Surgery
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Sundaram Dermatology, Cosmetic & Laser Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female, at least 30 years old
• Moderate submental (neck) fat
• Mild to moderate submental (neck) skin laxity (loose skin)
• Willing and able to provide informed consent
• Willing and able to comply with all protocol requirements
• Willing to limit direct sun exposure and use sunscreen for duration of the study
• Agree to maintain weight for duration of the study
• Willing to have photographs taken that could identify the participant

Exclusion Criteria:

• Previous intervention to treat submental fat or skin laxity
• Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
• Sensitivity to local anesthesia
• Severe acne, cystic acne or acne scars on neck
• Trauma of chin or neck area
• Skin infection or rash on neck
• Psoriasis, eczema, rosacea, or vitiligo
• History of scarring
• History or current symptoms of dysphagia
• Chronic or persistent coughing
• Body mass index (BMI) > 30
• Clinically significant bleeding disorder
• Anemia, kidney disease, or liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotational fractional resection (1.5mm diameter device); Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)	Device: Rotational fractional resection (1.5mm diameter device); Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2	This endpoint is the difference in the measurement of submental skin area (mm^2) between Baseline and 90 days. A reduction of ≥ 20 mm^2 denotes improvement.	Baseline and 90 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied", "satisfied", or "very satisfied").	90 days after treatment
Number of Participants With Post-treatment Images Correctly Identified	Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects	Pre-treatment and 90 days after treatment

Collaborators and Investigators

• Sponsor: Recros Medica, Inc.
• Investigators: Study Director: Edward W Knowlton, MD, Recros Medica, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Submental fat; Submental fullness; Loose skin
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Lipid Metabolism Disorders; Skin Diseases, Metabolic; Lipodystrophy
• Other Study ID Numbers: CLP-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No