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NCT Number: NCT03966924

The PREFORM Study: Rotational Fractional Resection for Submental Contouring

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.

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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

Steve Yoelin, MD Medical Associates, Inc.

Newport Beach, California, 92663, United States

About this study

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.

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 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

Treatment and study plan

Rotational fractional resection (1.5mm diameter device)

Device

Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Primary outcomes

  1. Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale

    Time frame: 90 days post treatment

    Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Secondary outcomes

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

    Time frame: 90 days post 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 a One Grade Improvement on the Submental Lipodystrophy Scale

    Time frame: 90 days post treatment

    Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Sponsors and collaborators

Lead sponsor

Recros Medica, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2019
Registry last updated
May 11, 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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