CONFORM: Rotational Fractional Resection for Submental Contouring

• ClinicalTrials.gov Identifier: NCT03407313
• Recruitment Status: Completed
• First Posted: January 23, 2018
• Results First Posted: February 3, 2021
• Last Update Posted: February 3, 2021
• Sponsor: Recros Medica, Inc.
• Information provided by (Responsible Party): Recros Medica, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Skin Laxity; Lipodystrophy	Device: Rotational fractional resection (1.5mm diameter device)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
• Actual Study Start Date: January 8, 2018
• Actual Primary Completion Date: December 28, 2018
• Actual Study Completion Date: April 23, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 [ Time Frame: Baseline and 90 days post treatment ]
   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.

Secondary Outcome Measures :

1. Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline [ Time Frame: 90 days after treatment ]
   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").
2. Number of Participants With Post-treatment Images Correctly Identified [ Time Frame: Pre-treatment and 90 days after treatment ]
   Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Aesthetx

Campbell, California, United States, 95008

Steve Yoelin, MD Medical Associates, Inc.

Newport Beach, California, United States, 92663

Roseville Facial Plastic Surgery

Roseville, California, United States, 95661

United States, Florida

Miami Dermatology & Laser Institute

Miami, Florida, United States, 33173

United States, Illinois

DeNova Research

Chicago, Illinois, United States, 60611

United States, Virginia

Sundaram Dermatology, Cosmetic & Laser Surgery Center

Fairfax, Virginia, United States, 22031

Sponsors and Collaborators

Recros Medica, Inc.

Investigators

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

  Study Documents (Full-Text)

Documents provided by Recros Medica, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] October 18, 2018

More Information

• Responsible Party: Recros Medica, Inc.
• ClinicalTrials.gov Identifier: NCT03407313
• Other Study ID Numbers: CLP-0002
• First Posted: January 23, 2018
• Results First Posted: February 3, 2021
• Last Update Posted: February 3, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Recros Medica, Inc.:

Submental fullness; Submental fat; Loose skin

Additional relevant MeSH terms:

Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Lipid Metabolism Disorders; Metabolic Diseases