CONFORM: Rotational Fractional Resection for Submental Contouring

Lipodystrophy Clinical Trial

Official title:

The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407313
• Other study ID #: CLP-0002
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: April 23, 2019

Study information

• Verified date: January 2021
• Source: Recros Medica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

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 and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 23, 2019
• Est. primary completion date: December 28, 2018
• 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 submental (neck) fat

• Mild to moderate submental (neck) skin laxity (loose skin)

• Willing and able to provide informed consent

• Willing and able to comply with all protocol requirements

• Willing to limit direct sun exposure and use sunscreen for duration of the study

• Agree to maintain weight for duration of the study

• Willing to have photographs taken that could identify the participant

Exclusion Criteria:

• Previous intervention to treat submental fat or skin laxity

• Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure

• Sensitivity to local anesthesia

• Severe acne, cystic acne or acne scars on neck

• Trauma of chin or neck area

• Skin infection or rash on neck

• Psoriasis, eczema, rosacea, or vitiligo

• History of scarring

• History or current symptoms of dysphagia

• Chronic or persistent coughing

• Body mass index (BMI) > 30

• Clinically significant bleeding disorder

• Anemia, kidney disease, or liver disease

Related Conditions & MeSH terms

• Lipodystrophy
• Skin Laxity

Intervention

Device:
• Rotational fractional resection (1.5mm diameter device)
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Locations

Country	Name	City	State
United States	Aesthetx	Campbell	California
United States	DeNova Research	Chicago	Illinois
United States	Sundaram Dermatology, Cosmetic & Laser Surgery Center	Fairfax	Virginia
United States	Miami Dermatology & Laser Institute	Miami	Florida
United States	Steve Yoelin, MD Medical Associates, Inc.	Newport Beach	California
United States	Roseville Facial Plastic Surgery	Roseville	California

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	Number of Participants With a Reduction of Submental Skin Area = 20 mm^2	This endpoint is the difference in the measurement of submental skin area (mm^2) between Baseline and 90 days. A reduction of = 20 mm^2 denotes improvement.	Baseline and 90 days post treatment
Secondary	Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied", "satisfied", or "very satisfied").	90 days after treatment
Secondary	Number of Participants With Post-treatment Images Correctly Identified	Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects	Pre-treatment and 90 days after treatment