Lipodystrophy, Skin Laxity
Conditions
Keywords
submental, laxity, lipodystrophy
Brief summary
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.
Detailed description
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.
Interventions
Single treatment of skin resection and with and without 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | 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). |
| Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat) | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Age, Continuous | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 | 0 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 | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
| Submental Skin Laxity Scale score Moderate | 1 Participants |
| Submental Skin Laxity Scale score Severe | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Time frame: 90 days post treatment
Population: Number of participants with at least a one grade improvement on the Submental Skin Laxity Scale
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale | 2 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 post treatment
Population: Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
| 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 | 2 Participants |
Secondary
Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale
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)
Time frame: 90 days post treatment
Population: 1 grade improvement (Mild to None)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale | 2 Participants |