Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational fractional resection (1.5mm diameter device) | Experimental | Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational fractional resection (1.5mm diameter device) | Device | Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | 90 days after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edward W Knowlton, MD | Recros Medica, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetx | Campbell | California | 95008 | United States | ||
| Steve Yoelin, MD Medical Associates, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rotational Fractional Resection (1.5mm Diameter Device) | Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rotational Fractional Resection (1.5mm Diameter Device) | Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline and 90 days post treatment |
|
|
180 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotational Fractional Resection (1.5mm Diameter Device) | Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site erythema | Injury, poisoning and procedural complications | Non-systematic Assessment |
This study evaluated 1.5mm diameter skin resections, our first-generation prototype, in the submentum area.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Recros Medica | 925-223-8581 | clinical@recrosmedica.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2018 | Sep 22, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Pre-treatment and 90 days after treatment |
| Newport Beach |
| California |
| 92663 |
| United States |
| Roseville Facial Plastic Surgery | Roseville | California | 95661 | United States |
| Miami Dermatology & Laser Institute | Miami | Florida | 33173 | United States |
| DeNova Research | Chicago | Illinois | 60611 | United States |
| Sundaram Dermatology, Cosmetic & Laser Surgery Center | Fairfax | Virginia | 22031 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type (Grades I through IV) is a numerical classification schema for human skin color | Count of Participants | 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"). | Posted | Count of Participants | Participants | 90 days after treatment |
|
|
|
| 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 | 68 subjects were assessed by three blinded reviewers | Posted | Count of Participants | Participants | Pre-treatment and 90 days after treatment |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 45 |
| 68 |
| Administration site bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contact Dermatitis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypoaesthesia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin Mass | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abnormal Skin Texture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012875 | Skin Diseases, Metabolic |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Title | Measurements |
|---|---|
|