Brief Title
The PREFORM Study: Rotational Fractional Resection for Submental Contouring
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
Brief 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.
Detailed 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.
Study Type
Interventional
Primary Outcome
Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
Secondary Outcome
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Condition
Skin Laxity
Intervention
Rotational fractional resection (1.5mm Diameter Device)
Study Arms / Comparison Groups
Rotational fractional resection (1.5mm Diameter Device)
Description: Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
2
Start Date
March 20, 2019
Completion Date
October 16, 2019
Primary Completion Date
October 16, 2019
Eligibility Criteria
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
Gender
All
Ages
30 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Robin McIntosh, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03966924
Organization ID
CLP-0007
Responsible Party
Sponsor
Study Sponsor
Recros Medica, Inc.
Study Sponsor
Robin McIntosh, Study Director, Recros Medica
Verification Date
January 2020