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.

Study Overview

• Status: Unknown
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Focal Contouring System

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Aesthetx
    • Encino, California, United States, 91436
      • Clinical Testing of Beverly Hills
    • Los Angeles, California, United States, 90025
      • Westside Aesthetics
    • Santa Monica, California, United States, 90404
      • ATS Clinical Research
    • Vista, California, United States, 92083
      • Moradi MD
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Research
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • Washington Institute of Dermatologic Laser Surgery
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
  • New York
    • New York, New York, United States, 10022
      • Juva Skin and Laser Center
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Brian Biesman, MD
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Sundaram Dermatology, Cosmetic & Laser Surgery Center
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rotational fractional resection (RFR); Single treatment of skin resection (removal of loose skin)	Device: Focal Contouring System; Single treatment of skin resection (removal of loose skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Pre-treatment and 90 days after treatment

Collaborators and Investigators

• Sponsor: Recros Medica, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2019
• Primary Completion (ANTICIPATED): October 31, 2020
• Study Completion (ANTICIPATED): October 31, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (ACTUAL): February 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: submental; laxity
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: CLP-0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No