An interventional study of Rotational fractional resection (1.5mm Diameter Device) in Skin Laxity and Lipodystrophy, sponsored by Recros Medica, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-11.
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. Rotational fractional resection is used to remove loose skin and fat.
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.
Exclusion Criteria:
Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Device: Rotational fractional resection (1.5mm Diameter Device)
Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
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
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
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
| Milestone | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
| 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 |
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 | 2 |
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)
| Participants | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale | 2 |
Collected over 90 days post treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotational Fractional Resection (1.5mm Diameter Device) | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Event | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Skin irritationSkin and subcutaneous tissue disorders | 1/2 |
| Age, Continuous(years) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Mean | 57 (55 to 59) |
| Sex: Female, Male(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Female | 2 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| 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 | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Submental Skin Laxity Scale score(Participants) | Rotational Fractional Resection (1.5mm Diameter Device) |
|---|---|
| Moderate | 1 |
| Severe | 1 |
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