The INFORM Study: Rotational Fractional Resection for Submental Contouring

Not Applicable

• Conditions: Skin Laxity
• Interventions: Device: Focal Contouring System

• Registration Number: NCT03853980
• Lead Sponsor: Recros Medica, Inc.

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-26
• Study Start: 2019-03-18
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotational fractional resection (RFR)	Focal Contouring System	Single treatment of skin resection (removal of loose skin)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

DeNova Research; 🇺🇸 Chicago, Illinois, United States

Aesthetx; 🇺🇸 Campbell, California, United States

Clinical Testing of Beverly Hills; 🇺🇸 Encino, California, United States

Westside Aesthetics; 🇺🇸 Los Angeles, California, United States

ATS Clinical Research; 🇺🇸 Santa Monica, California, United States

AboutSkin Research; 🇺🇸 Greenwood Village, Colorado, United States

Moradi MD; 🇺🇸 Vista, California, United States

Washington Institute of Dermatologic Laser Surgery; 🇺🇸 Washington, District of Columbia, United States

Juva Skin and Laser Center; 🇺🇸 New York, New York, United States

Bellaire Dermatology Associates; 🇺🇸 Bellaire, Texas, United States

Sundaram Dermatology, Cosmetic & Laser Surgery Center; 🇺🇸 Fairfax, Virginia, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Brian Biesman, MD; 🇺🇸 Nashville, Tennessee, United States

Clinical Research Center of the Carolinas; 🇺🇸 Charleston, South Carolina, United States