The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Lipodystrophy Clinical Trial

Official title:

The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966924
• Other study ID #: CLP-0007
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: October 16, 2019

Study information

• Verified date: January 2020
• 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. Rotational fractional resection is used to remove loose skin and fat.

Description:

This is a prospective, single-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 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, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• 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
• Up to moderate submental lipodystrophy
• Agree to maintain weight (±5%) for the duration of the study

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
• 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

• Lipodystrophy
• Skin Laxity

Intervention

Device:
• Rotational fractional resection (1.5mm Diameter Device)
Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Locations

Country	Name	City	State
United States	Steve Yoelin, MD Medical Associates, Inc.	Newport Beach	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 Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale	Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)	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 post treatment
Secondary	Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale	Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)	90 days post treatment