Trial Outcomes & Findings for CONFORM: Rotational Fractional Resection for Submental Contouring (NCT NCT03407313)

NCT ID: NCT03407313

Last Updated: 2021-02-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: Baseline and 90 days post treatment
• Results posted on: 2021-02-03

Participant Flow

Participant milestones

Measure	Rotational Fractional Resection (1.5mm Diameter Device) Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
Overall Study STARTED	68
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CONFORM: Rotational Fractional Resection for Submental Contouring

Baseline characteristics by cohort

Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=68 Participants Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
Age, Continuous	56.9 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 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	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (BMI)	24.7 kg/m^2 STANDARD_DEVIATION 3.1 • n=5 Participants
Fitzpatrick Skin Type Type I - Ivory white (pale white); extremely fair skin	2 Participants n=5 Participants
Fitzpatrick Skin Type Type II - White or fair skin	36 Participants n=5 Participants
Fitzpatrick Skin Type Type III - Medium white skin	30 Participants n=5 Participants
Fitzpatrick Skin Type Type IV - Beige or lightly tanned or olive skin	0 Participants n=5 Participants
Fitzpatrick Skin Type Type V - Moderately brown or tanned brown skin	0 Participants n=5 Participants
Fitzpatrick Skin Type Type VI - Dark brown or black skin	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 90 days post treatment

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.

Outcome measures

Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=68 Participants Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2	49 Participants

SECONDARY outcome

Timeframe: 90 days after treatment

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

Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=68 Participants Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	56 Participants

SECONDARY outcome

Timeframe: Pre-treatment and 90 days after treatment

Population: 68 subjects were assessed by three blinded reviewers

Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects

Outcome measures

Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=68 Participants Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
Number of Participants With Post-treatment Images Correctly Identified Blinded Reviewer 1	59 Participants
Number of Participants With Post-treatment Images Correctly Identified Blinded Reviewer 2	67 Participants
Number of Participants With Post-treatment Images Correctly Identified Blinded Reviewer 3	67 Participants

Adverse Events

Rotational Fractional Resection (1.5mm Diameter Device)

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rotational Fractional Resection (1.5mm Diameter Device) n=68 participants at risk Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
Injury, poisoning and procedural complications Administration site erythema	16.2% 11/68 • 180 days
Injury, poisoning and procedural complications Administration site bruising	16.2% 11/68 • 180 days
Injury, poisoning and procedural complications Contact Dermatitis	5.9% 4/68 • 180 days
Injury, poisoning and procedural complications Hypoaesthesia	5.9% 4/68 • 180 days
Skin and subcutaneous tissue disorders Skin Mass	7.4% 5/68 • 180 days
Injury, poisoning and procedural complications Abnormal Skin Texture	8.8% 6/68 • 180 days
Gastrointestinal disorders Nausea	5.9% 4/68 • 180 days

Additional Information

Head of Clinical Development

Recros Medica

Phone: 925-223-8581

Email: clinical@recrosmedica.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60