The INFORM Study: Rotational Fractional Resection for Submental Contouring

The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan

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.

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