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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
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Recros Medica, Inc.

Study Description
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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 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
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rotational fractional resection
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
 Device: Rotational fractional resection
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)


Outcome Measures
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Primary Outcome Measures :
  1. Improved Skin Laxity or Lipodystrophy [ Time Frame: Pre-treatment and 90 days after treatment ]
    0.75 mean grade reduction in score on Submental Skin Laxity or Submental Lipodystrophy Scales


Secondary Outcome Measures :
  1. Improved Skin Laxity [ Time Frame: Pre-treatment and 90 days after treatment ]
    One grade or better reduction in score on Submental Skin Laxity (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

  2. Improved Lipodystrophy [ Time Frame: Pre-treatment and 90 days after treatment ]
    One grade or better reduction in score on Submental Lipodystrophy Scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

  3. Subject Satisfaction [ Time Frame: 90 days after treatment ]
    Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire

  4. Improved Submental Contouring [ 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
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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
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Information from the National Library of Medicine

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


Locations
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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
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Study Director: Edward W Knowlton, MD Recros Medica, Inc.
More Information
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Responsible Party: Recros Medica, Inc.
ClinicalTrials.gov Identifier: NCT03407313    
Other Study ID Numbers: CLP-0002
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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