Trial Outcomes & Findings for Cryolipolysis and Subcision for Treatment of Cellulite (NCT NCT01209767)

NCT ID: NCT01209767

Last Updated: 2021-12-03

Results Overview

Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-12-03

Participant Flow

Participant milestones

Measure	Subjects Receiving Split Body Treatment The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision. cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Overall Study STARTED	22
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Subjects Receiving Split Body Treatment The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision. cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	3

Baseline Characteristics

Cryolipolysis and Subcision for Treatment of Cellulite

Baseline characteristics by cohort

Measure	Subjects Receiving Split Body Treatment n=22 Participants The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision. cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.4 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.

Outcome measures

Measure	Cryolipolysis n=18 Participants cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite	Subcision n=18 Participants Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.	Control n=18 Participants Area that received no treatment
Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.	22.22 Percentage of participants Interval 6.41 to 47.64	33.33 Percentage of participants Interval 13.34 to 59.01	44.44 Percentage of participants Interval 21.53 to 69.24

Adverse Events

Cryolipolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subcision

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cryolipolysis n=22 participants at risk cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite	Subcision n=22 participants at risk Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.	Control n=22 participants at risk Nothing was done to the area.
General disorders small ulcer	0.00% 0/22	4.5% 1/22 • Number of events 1	0.00% 0/22
General disorders lumps	0.00% 0/22	9.1% 2/22	0.00% 0/22

Additional Information

Dr. Murad Alam

Northwestern University

Phone: 312-695-4761

Email: m-alam@northwestern.edu

Results disclosure agreements

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