The INFORM Study: Rotational Fractional Resection for Submental Contouring

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03853980
• Other study ID #: CLP-0006
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: March 2020
• Source: Recros Medica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Focal Contouring System
Single treatment of skin resection (removal of loose skin)

Locations

Country	Name	City	State
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Aesthetx	Campbell	California
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	DeNova Research	Chicago	Illinois
United States	Clinical Testing of Beverly Hills	Encino	California
United States	Sundaram Dermatology, Cosmetic & Laser Surgery Center	Fairfax	Virginia
United States	AboutSkin Research	Greenwood Village	Colorado
United States	Westside Aesthetics	Los Angeles	California
United States	Brian Biesman, MD	Nashville	Tennessee
United States	Juva Skin and Laser Center	New York	New York
United States	ATS Clinical Research	Santa Monica	California
United States	Premier Clinical Research	Spokane	Washington
United States	Moradi MD	Vista	California
United States	Washington Institute of Dermatologic Laser Surgery	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Recros Medica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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