The INFORM Study: Rotational Fractional Resection for Submental Contouring

Recros Medica

Status

Unknown

Conditions

Skin Laxity

Treatments

Device: Focal Contouring System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03853980

CLP-0006

Details and patient eligibility

About

Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.

Full 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) 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, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Enrollment

21 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
Agree to maintain weight (±5%) for the duration of the study

Exclusion criteria

Greater than mild submental fat
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