The INFORM Study: Rotational Fractional Resection for Submental Contouring

Recros Medica, Inc.21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Laxity

Interventions

Focal Contouring SystemDEVICE

Single treatment of skin resection (removal of loose skin)

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (14)

Aesthetx

Campbell, California, United States

Clinical Testing of Beverly Hills

Encino, California, United States

Westside Aesthetics

Los Angeles, California, United States

Outcomes

Primary Outcomes

Improved Skin Laxity

Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Time frame: Pre-treatment and 90 days after treatment

Subject Satisfaction: Subject Satisfaction Questionnaire

Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire

Time frame: Pre-treatment and 90 days after treatment

Data from ClinicalTrials.gov

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