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CONFORM: Rotational Fractional Resection for Submental Contouring

Primary Purpose

Skin Laxity, Lipodystrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotational fractional resection (1.5mm diameter device)
Sponsored by
Recros Medica, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Laxity focused on measuring Submental fullness, Submental fat, Loose skin

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aesthetx
  • Steve Yoelin, MD Medical Associates, Inc.
  • Roseville Facial Plastic Surgery
  • Miami Dermatology & Laser Institute
  • DeNova Research
  • Sundaram Dermatology, Cosmetic & Laser Surgery Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rotational fractional resection (1.5mm diameter device)

Arm Description

Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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").
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

Full Information

First Posted
January 16, 2018
Last Updated
January 15, 2021
Sponsor
Recros Medica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03407313
Brief Title
CONFORM: Rotational Fractional Resection for Submental Contouring
Official Title
The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
April 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Recros Medica, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Lipodystrophy
Keywords
Submental fullness, Submental fat, Loose skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotational fractional resection (1.5mm diameter device)
Arm Type
Experimental
Arm Description
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
Intervention Type
Device
Intervention Name(s)
Rotational fractional resection (1.5mm diameter device)
Intervention Description
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
Primary Outcome Measure Information:
Title
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
Description
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.
Time Frame
Baseline and 90 days post treatment
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Description
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").
Time Frame
90 days after treatment
Title
Number of Participants With Post-treatment Images Correctly Identified
Description
Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects
Time Frame
Pre-treatment and 90 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward W Knowlton, MD
Organizational Affiliation
Recros Medica, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Aesthetx
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Steve Yoelin, MD Medical Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Roseville Facial Plastic Surgery
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Miami Dermatology & Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sundaram Dermatology, Cosmetic & Laser Surgery Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CONFORM: Rotational Fractional Resection for Submental Contouring

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