CONFORM: Rotational Fractional Resection for Submental Contouring
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03407313 |
Recruitment Status :
Completed
First Posted : January 23, 2018
Results First Posted : February 3, 2021
Last Update Posted : February 3, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Laxity Lipodystrophy | Device: Rotational fractional resection (1.5mm diameter device) | Not Applicable |
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 |

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) |
- 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.
- 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").
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407313
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 |
Study Director: | Edward W Knowlton, MD | Recros Medica, Inc. |
Documents provided by Recros Medica, Inc.:
Responsible Party: | Recros Medica, Inc. |
ClinicalTrials.gov Identifier: | NCT03407313 |
Other Study ID Numbers: |
CLP-0002 |
First Posted: | January 23, 2018 Key Record Dates |
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 |
Submental fullness Submental fat Loose skin |
Lipodystrophy Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |