CONFORM: Rotational Fractional Resection for Submental Contouring

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2019-04-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Skin Laxity Lipodystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rotational fractional resection (1.5mm diameter device)

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

Group Type EXPERIMENTAL

Rotational fractional resection (1.5mm diameter device)

Intervention Type DEVICE

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

Interventions

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Rotational fractional resection (1.5mm diameter device)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes