The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Recros Medica

Status

Completed

Conditions

Lipodystrophy

Skin Laxity

Treatments

Device: Rotational fractional resection (1.5mm Diameter Device)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03966924

CLP-0007

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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