The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Not Applicable

Completed

• Conditions: Lipodystrophy; Skin Laxity
• Interventions: Device: Rotational fractional resection (1.5mm Diameter Device)

• Registration Number: NCT03966924
• Lead Sponsor: Recros Medica, Inc.

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 Timeline

• Study First Submitted: 2019-03-19
• Study Start: 2019-03-20
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Status Verified: 2020-01
• Results First Submitted: 2021-01-25
• Results First Submitted QC: 2021-01-25
• Results First Posted: 2021-02-11
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotational fractional resection (1.5mm Diameter Device)	Rotational fractional resection (1.5mm Diameter Device)	Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale	90 days post treatment	Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	90 days post 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 a One Grade Improvement on the Submental Lipodystrophy Scale	90 days post treatment	Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Trial Locations

Locations (1)

Steve Yoelin, MD Medical Associates, Inc.; 🇺🇸 Newport Beach, California, United States