Lipodystrophy, Skin Laxity
Conditions
Keywords
Submental fullness, Submental fat, Loose skin
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 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.
Interventions
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
Sponsors
Recros Medica, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | 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). |
| Number of Participants With Post-treatment Images Correctly Identified | Pre-treatment and 90 days after treatment | Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 6.7 |
| Body Mass Index (BMI) | 24.7 kg/m^2 STANDARD_DEVIATION 3.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Type III - Medium white skin | 30 Participants |
| Fitzpatrick Skin Type Type I - Ivory white (pale white); extremely fair skin | 2 Participants |
| Fitzpatrick Skin Type Type II - White or fair skin | 36 Participants |
| Fitzpatrick Skin Type Type IV - Beige or lightly tanned or olive skin | 0 Participants |
| Fitzpatrick Skin Type Type VI - Dark brown or black skin | 0 Participants |
| Fitzpatrick Skin Type Type V - Moderately brown or tanned brown skin | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 45 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
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.
Time frame: Baseline and 90 days post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 | 49 Participants |
Secondary
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
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).
Time frame: 90 days after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | 56 Participants |
Secondary
Number of Participants With Post-treatment Images Correctly Identified
Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects
Time frame: Pre-treatment and 90 days after treatment
Population: 68 subjects were assessed by three blinded reviewers
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants With Post-treatment Images Correctly Identified | Blinded Reviewer 1 | 59 Participants |
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants With Post-treatment Images Correctly Identified | Blinded Reviewer 2 | 67 Participants |
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants With Post-treatment Images Correctly Identified | Blinded Reviewer 3 | 67 Participants |