CONFORM: 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. RFR is used to remove loose skin and fat.

Key facts

Study ID

NCT03407313

Run by

Recros Medica, Inc.

People needed

68

Starts

2018-01-08

Expected to finish

2019-04-23

Last updated by the study team

2021-02-03

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 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

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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