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Completed

NCT Number: NCT03407313

CONFORM: Rotational Fractional Resection for Submental Contouring

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.

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Genetic Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aesthetx, Campbell, California, United States

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About this study

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 Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Rotational fractional resection (1.5mm diameter device)

Device

Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Primary outcomes

  1. Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2

    Time frame: Baseline and 90 days post treatment

    This endpoint is the difference in the measurement of submental skin area (mm^2) between Baseline and 90 days. A reduction of ≥ 20 mm^2 denotes improvement.

Secondary outcomes

  1. Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline

    Time frame: 90 days after treatment

    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").

  2. Number of Participants With Post-treatment Images Correctly Identified

    Time frame: Pre-treatment and 90 days after treatment

    Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects

Sponsors and collaborators

Lead sponsor

Recros Medica, Inc.

Industry

Registry information

Official study title

The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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