Efficacy, Safety, and Subject Satisfaction Using Rotational Fractional Resection for the Improvement of

Submental Contouring

Steve Dayan, MD; Jill Waibel, MD; Steve Yoelin, MD

• Rotational Fractional Resection (RFR) is a novel, minimally invasive surgical skin contouring procedure

that is an alternative to the traditional surgical approach, liposuction combined with facelift, and more

recent treatments for reducing adipocyte density, such as injectable chemical lipolytic agents (eg,

Kybella) or cryolipolysis (ie, CoolSculpting).

• RFR uses small (1.5 mm diameter) rotating, cylindrical scalpels to resect lax skin and a small rotating

lipectomy cannula to perform focal lipectomy through fractionally resected access ports.

• Directed closure of the resected sites using an elastic adhesive membrane assures healing and

supports the focal contouring effect. The procedure can be performed in-office and is conducted

under local anesthesia.

• Preliminary experience has indicated that RFR may be effective for reducing skin laxity.

• The CONFORM study (NCT03407313) was designed to further investigate the effectiveness of RFR for

submental contouring by removing excess skin and fat.

• The objective of this study is to evaluate the efficacy, tolerability, and subject satisfaction of the Recros

Medica Focal Contouring System to improve submental contouring using RFR.

INTRODUCTION

OBJECTIVE

• This is a prospective, multi-center, single-arm, non-significant risk study.

• 68 adult subjects with mild to moderate submental fat and skin laxity were enrolled.

• Each subject was assessed at baseline and at days 1, 7, 14, 30, 90, and 180 after the procedure visit.

• Interim efficacy was assessed using the 5-point Submental Skin Laxity (SSL) and Submental

Lipodystrophy (SL) Scales. Subject satisfaction was also evaluated using a questionnaire with subject-

reported outcomes (a 6-point Subject Satisfaction Scale and a 5-point Likeliness to Recommend Scale).

The reported results represent interim data for 31 patients at Day 30.

• Tolerability was determined by physician-reported visual skin assessment (VSA) and pain assessment

on an 11-point numeric rating scale.

STUDY DESIGN

• A total of 31 patients with mild to moderate submental skin laxity were analyzed at the 30-day

timepoint.

Baseline Characteristics

Submental Skin Laxity and Fat

• There was a mean 1-point improvement in both SSL and SL scales at Day 30.

• The majority of subjects had a ≥1-grade improvement in the SSL and SL scales at Day 30.

• A greater proportion of subjects with moderate submental laxity and fat at baseline showed a ≥1-

grade improvement.

Representative Subject Cases (Pre– and Post-Procedural at Day 30)

RESULTS

Characteristic

Number of patients 31

Age, mean, years (range) 54 (40—68)

Female, n (%) 27 (87)

Caucasian, n (%) 31 (100)

Body-mass index, mean, kg/m2 23.8

Fitzpatrick skin type, n (%) I II III

2 (6)

14 (45) 15 (48)

Submental skin laxity Mean scorea

Mild, n (%) Moderate, n (%)

1.58

13 (42) 18 (58)

Submental fat Mean scorea

Mild, n (%) Moderate, n (%)

1.48

16 (52) 15 (48)

Subject satisfaction with appearance, n (%) Mean scoreb Very dissatisfied Dissatisfied Somewhat dissatisfied

0.77

12 (39) 14 (45) 5 (16)

Tolerability

• Subjects reported minimal post-procedural pain.

• There were no reports of severe adverse effects after RFR based on physician VSA.

• At Day 30, 6% of subjects had physician-reported signs of visible scarring.

Subject Satisfaction

• There was high subject satisfaction with appearance, recovery time, and the procedure.

• Most subjects were likely to recommend RFR to friends or family.

a Submental Skin Laxity/Lipodystrophy Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe. b Subject Satisfaction Scale: 0 = Very Dissatisfied, 1 = Dissatisfied, 2 = Somewhat Dissatisfied, 3 = Somewhat Satisfied, 4 = Satisfied, 5 = Very Satisfied.

• Interim data from the CONFORM study indicates that RFR improves the appearance of submental

contouring within days after a single procedure with good tolerability in subjects with mild-to-

moderate skin laxity and lipodystrophy.

CONCLUSIONS

• Treatment with RFR has resulted in a mean 1-grade improvement in Investigator-evaluated skin laxity

and lipodystrophy at 30 days.

• At 30 days, 84% of subjects were satisfied with their neck and jawline appearance and 97% of subjects

were likely to recommend the procedure to others.

• There was minimal procedural and post-procedural pain, no visible scarring in 94% of subjects, and no

severe skin-related adverse effects.

SUMMARY

Mean score, Investigator-reported outcomes (5-point scales) at Day 30 (N=31).

Submental Scale

Skin Laxity Lipodystrophy

All patients (n=31)

2-grade improvement, n (%) 6 (19) 7 (23)

≥1-grade improvement, n (%) 25 (81) 23 (74)

≥1-grade improvement on both scales, n (%) 21 (68)

Patients with moderate laxity and fat at baseline

n 18 15

2-grade improvement, n (%) 6 (33) 7 (47)

≥1-grade improvement, n (%) 16 (89) 13 (87)

a Subject-reported outcomes on the 6-point Subject Satisfaction Scale (N=31). b Baseline score, 0.77. c Percentage of patients reporting Somewhat Satisfied (3), Satisfied (4), or Very Satisfied (5) on the Subject Satisfaction Scale. d Percentage of patients reporting Somewhat Likely (3), Very Likely (4), or Extremely Likely (5) on the Likelihood to Recommend Scale.

Subject Satisfaction Rating Day 7 Day 14 Day 30

Neck and jawline appearance

Mean scorea,b

Patients satisfiedc, n (%)

3.42

27 (87)

3.65

27 (87)

3.52

26 (84)

Recovery time Mean scorea

Percentage satisfiedc, n (%)

4.00

29 (94)

3.77

28 (90)

3.26

23 (74)

Procedure results Mean scorea

Percentage satisfiedc, n (%)

3.71

27 (87)

3.81

28 (90)

3.68

27 (87)

Recommend to friends/family Mean scorea

Percentage likelyd, n (%)

3.03

28 (90)

3.00

30 (97)

2.77

27 (87)

• This study was supported by Recros Medica.

• Medical writing assistance was provided by Kenneth Chiang, PhD.

ACKNOWLEDGEMENTS

2018 American Society of Dermatologic Surgery Annual Meeting; October 11-14, 2018; Phoenix, Arizona, USA. Poster #119.

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Mean score, subject-reported outcome (11-point scale) at Day 30 (N=31).

Adverse Effect, n (%) Day 7 Day 14 Day 30

Bruising None Mild Moderate

12 (39) 11 (35) 8 (26)

24 (77) 6 (19) 1 (3)

28 (90) 3 (10) 0 (0)

Erythema None Mild Moderate

0 (0)

21 (68) 10 (32)

2 (6)

23 (74) 6 (19)

6 (19)

19 (61) 6 (19)

Edema None Mild Moderate

16 (52) 13 (42)

2 (6)

17 (55) 13 (42)

1 (3)

21 (68) 9 (29) 1 (3)

Skin irregularity None Mild Moderate

15 (48) 11 (35) 5 (16)

16 (52) 8 (26) 7 (23)

15 (48) 11 (35) 5 (16)

Pigmentation None Mild Moderate

23 (74) 7 (26) 1 (3)

22 (71) 6 (19) 3 (10)

19 (61) 9 (29) 3 (10)

Subject-reported outcomes using the 5-point Likelihood to Recommend Scale (N=31).