An interventional study of Rotational fractional resection (1.5mm diameter device) in Skin Laxity and Lipodystrophy, sponsored by Recros Medica, Inc.. Completed at 6 sites in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Recros Medica, Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
Device: Rotational fractional resection (1.5mm diameter device)
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
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
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
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
| Milestone | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Started | 68 |
| Completed | 66 |
| Not completed | 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.
| Participants | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 | 49 |
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").
| Participants | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | 56 |
Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects
| Participants | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Blinded Reviewer 1 | 59 |
| Blinded Reviewer 2 | 67 |
| Blinded Reviewer 3 | 67 |
Collected over 180 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | 0/68 (0%) | 0/68 (0%) | 45/68 (66.2%) |
| Event | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Administration site erythemaInjury, poisoning and procedural complications | 11/68 |
| Administration site bruisingInjury, poisoning and procedural complications | 11/68 |
| Abnormal Skin TextureInjury, poisoning and procedural complications | 6/68 |
| Skin MassSkin and subcutaneous tissue disorders | 5/68 |
| Contact DermatitisInjury, poisoning and procedural complications | 4/68 |
| HypoaesthesiaInjury, poisoning and procedural complications | 4/68 |
| NauseaGastrointestinal disorders | 4/68 |
| Age, Continuous(years) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Mean | 56.9 ± 6.7 |
| Sex: Female, Male(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Female | 59 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 58 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 67 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Body Mass Index (BMI)(kg/m^2) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Mean | 24.7 ± 3.1 |
| Fitzpatrick Skin Type(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Type I - Ivory white (pale white); extremely fair skin | 2 |
| Type II - White or fair skin | 36 |
| Type III - Medium white skin | 30 |
| Type IV - Beige or lightly tanned or olive skin | 0 |
| Type V - Moderately brown or tanned brown skin | 0 |
| Type VI - Dark brown or black skin | 0 |
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