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.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's enrollment of 68 is above the median of 46 across 97 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →Recros Medica, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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