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Status:

COMPLETED

CONFORM: Rotational Fractional Resection for Submental Contouring

Lead Sponsor:

Recros Medica, Inc.

Conditions:

Skin Laxity

Lipodystrophy

Eligibility:

All Genders

30+ years

Phase:

NA

Brief 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.

Detailed 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 Resec...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 8 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 23 2019

Estimated Enrollment :

68 Patients enrolled

Trial Details

Trial ID

NCT03407313

Start Date

January 8 2018

End Date

April 23 2019

Last Update

February 3 2021

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

Aesthetx

Campbell, California, United States, 95008

2

Steve Yoelin, MD Medical Associates, Inc.

Newport Beach, California, United States, 92663

3

Roseville Facial Plastic Surgery

Roseville, California, United States, 95661

4

Miami Dermatology & Laser Institute

Miami, Florida, United States, 33173