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CONFORM: Rotational Fractional Resection for Submental Contouring

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ClinicalTrials.gov Identifier: NCT03407313
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Recros Medica, Inc.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


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



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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

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


Contacts
Contact: Robin McIntosh 714-309-7667 rmcintosh@recrosmedica.com

Locations
United States, California
Aesthetx Recruiting
Campbell, California, United States, 95008
Contact: Kyralyn Kawasaki-Yee, RN, BSN    408-559-7117    kyralyn@aesthetx.com   
Principal Investigator: Kamakshi R Zeidler, MD         
Sub-Investigator: R Laurence Berkowitz, MD         
Steve Yoelin, MD Medical Associates, Inc. Recruiting
Newport Beach, California, United States, 92663
Contact: Jo Lee    949-548-2711    auxiliary2@aol.com   
Contact: Thao Le    949-548-2711    letn89@gmail.com   
Roseville Facial Plastic Surgery Recruiting
Roseville, California, United States, 95661
Contact: Elizabeth Langlois    916-773-0395    Elizabeth.rfps@gmail.com   
Contact: Kathy Kettenhofen, CCMA    916-773-0395    kkettenhofen@sacent.com   
Principal Investigator: Jonathan M Sykes, MD         
Sub-Investigator: David J Kiener, MD         
United States, Illinois
DeNova Research Recruiting
Chicago, Illinois, United States, 60611
Contact: Selika Gutierrez- Borst, MS, RN    312-335-2070    selika@denovaresearch.com   
Principal Investigator: Steven H Dayan, MD         
United States, Minnesota
Zel Skin & Laser Specialists Recruiting
Edina, Minnesota, United States, 55424
Contact: Mona Selim    952-929-8888    mona.selim@unitedskin.com   
Principal Investigator: Brian Zelickson, MD         
Sub-Investigator: Karl Vance, MD         
Sponsors and Collaborators
Recros Medica, Inc.
Investigators
Study Director: Edward W Knowlton, MD Recros Medica, Inc.

Responsible Party: Recros Medica, Inc.
ClinicalTrials.gov Identifier: NCT03407313     History of Changes
Other Study ID Numbers: CLP-0002
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Cutis Laxa
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases