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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03853980

Enrollment

Registered

2019-02-26

Start date

2019-03-18

Completion date

2020-10-31

Last updated

2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Laxity

Keywords

submental, laxity

Brief summary

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

Detailed 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.

Interventions

DEVICEFocal Contouring System

Single treatment of skin resection (removal of loose skin)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Improved Skin Laxity	Pre-treatment and 90 days after treatment	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)
Subject Satisfaction: Subject Satisfaction Questionnaire	Pre-treatment and 90 days after treatment	Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026