The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Completed · Not applicable

Conditions studied: Skin Laxity, Lipodystrophy

In brief

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.

Key facts

Study ID

NCT03966924

Run by

Recros Medica, Inc.

People needed

2

Starts

2019-03-20

Expected to finish

2019-10-16

Last updated by the study team

2021-05-11

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Steve Yoelin, MD Medical Associates, Inc. — Newport Beach, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.