CONFORM: Rotational Fractional Resection for Submental Contouring

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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

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.

Study Type

Interventional

Primary Outcome

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2

Secondary Outcome

 Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline

Condition

Skin Laxity

Intervention

Rotational fractional resection (1.5mm diameter device)

Study Arms / Comparison Groups

 Rotational fractional resection (1.5mm diameter device)
Description:  Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

68

Start Date

January 8, 2018

Completion Date

April 23, 2019

Primary Completion Date

December 28, 2018

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

Gender

All

Ages

30 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Edward W Knowlton, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03407313

Organization ID

CLP-0002

Responsible Party

Sponsor

Study Sponsor

Recros Medica, Inc.

Study Sponsor

Edward W Knowlton, MD, Study Director, Recros Medica, Inc.

Verification Date

January 2021