The PREFORM Study: A Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

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Brief Title

The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Official Title

The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery

Brief Summary

      This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to
      improve neck contouring. Rotational fractional resection is used to remove loose skin and
      fat.

Detailed Description

      This is a prospective, single-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
      moderate to severe submental skin laxity. The total duration of study participation for each
      subject is approximately up to 4 months for each subject from the screening visit to the exit
      visit. The follow-up period will be approximately 3 months after the procedure. Eligible
      subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits
      at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Study Type

Interventional

Primary Outcome

Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale

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 with and without 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

2

Start Date

March 20, 2019

Completion Date

October 16, 2019

Primary Completion Date

October 16, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy male or female

          -  At least 30 years old

          -  Moderate to severe submental laxity

          -  Up to moderate submental lipodystrophy

          -  Agree to maintain weight (±5%) for the duration of the study

        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

          -  Severe acne, cystic acne or acne scars on neck

          -  Trauma of chin or neck area

          -  Skin infection or rash on neck

          -  Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo

          -  History of scarring

          -  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

Robin McIntosh, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03966924

Organization ID

CLP-0007

Responsible Party

Sponsor

Study Sponsor

Recros Medica, Inc.

Study Sponsor

Robin McIntosh, Study Director, Recros Medica

Verification Date

January 2020