Trial Outcomes & Findings for The PREFORM Study: Rotational Fractional Resection for Submental Contouring (NCT NCT03966924)

Last Updated: 2021-05-11

Results Overview

Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

90 days post treatment

Results posted on

2021-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Rotational Fractional Resection (1.5mm Diameter Device) Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=2 Participants Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Submental Skin Laxity Scale score Moderate	1 Participants n=5 Participants
Submental Skin Laxity Scale score Severe	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post treatment

Population: Number of participants with at least a 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)

Outcome measures

Outcome measures
Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=2 Participants 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	2 Participants

SECONDARY outcome

Timeframe: 90 days post treatment

Population: 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").

Outcome measures

Outcome measures
Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=2 Participants Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	2 Participants

SECONDARY outcome

Timeframe: 90 days post treatment

Population: 1 grade improvement (Mild to None)

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)

Outcome measures

Outcome measures
Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=2 Participants Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale	2 Participants

Adverse Events

Rotational Fractional Resection (1.5mm Diameter Device)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=2 participants at risk Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Skin and subcutaneous tissue disorders Skin irritation	50.0% 1/2 • Number of events 1 • 90 days post treatment

Additional Information

Head of Clinical Development

Recros Medica

Phone: 925-223-8581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60