Trial Outcomes & Findings for Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis (NCT NCT01673113)

Results Overview

VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a "stop" button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

within 48-72 hours after treatment

Results posted on

2019-10-01

Participant Flow

11 subjects were randomized to have either left or right flank treated. The untreated flank served as the internal control for each subject.

Unit of analysis: flanks

Participant milestones

Participant milestones
Measure	Treatment Subjects were randomized to have either left or right flank treated with cryolipolysis.	Control The untreated flank of each subject served as internal control.
Overall Study STARTED	11 11	11 11
Overall Study COMPLETED	11 11	11 11
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=11 flanks Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device	Control n=11 flanks The untreated flank of each subject served as the internal control.	Total n=22 flanks Total of all reporting groups
Age, Categorical <=18 years	0 flanks n=20 flanks	0 flanks n=11 flanks	0 flanks n=22 flanks
Age, Categorical Between 18 and 65 years	11 flanks n=20 flanks	11 flanks n=11 flanks	22 flanks n=22 flanks
Age, Categorical >=65 years	0 flanks n=20 flanks	0 flanks n=11 flanks	0 flanks n=22 flanks
Sex: Female, Male Female	6 flanks n=20 flanks	6 flanks n=11 flanks	12 flanks n=22 flanks
Sex: Female, Male Male	5 flanks n=20 flanks	5 flanks n=11 flanks	10 flanks n=22 flanks
Region of Enrollment United States	11 flanks n=20 flanks	11 flanks n=11 flanks	22 flanks n=22 flanks
BMI of <30	11 flanks n=20 flanks	11 flanks n=11 flanks	22 flanks n=22 flanks

PRIMARY outcome

Timeframe: within 48-72 hours after treatment

Population: 11 subjects were randomized to have right or left flank treated with cryolipolysis. The untreated flank served as the internal control.

VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a "stop" button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats.

Outcome measures

Outcome measures
Measure	Treatment n=11 flanks Cryolipolysis treated flanks had vibration sensory testing done within 48-72 hours after treatment.	Control n=11 flanks Untreated flanks of each subject had vibration sensory testing done within 48-72 hours after treatment.
Vibration Detection Threshold (VDT)	26.3 (um/sec) Interval 20.9 to 31.7	19 (um/sec) Interval 13.6 to 24.4

SECONDARY outcome

Timeframe: 48-72 hours post treatment

Population: 11 subjects were randomized to have right or left flank treated with cryolipolysis and the untreated flank served as internal control.

MDT was evaluated using von Frey Filaments. The up-down method, which evaluates the threshold force for appearance and disappearance of a touch sensation reported by the subject, was used until 3 values were obtained. The values presented in the data table were averaged over all repeats.

Outcome measures

Outcome measures
Measure	Treatment n=11 flanks Cryolipolysis treated flanks had vibration sensory testing done within 48-72 hours after treatment.	Control n=11 flanks Untreated flanks of each subject had vibration sensory testing done within 48-72 hours after treatment.
Mechanical Detection Threshold (MDT)	0.87 grams Interval 0.4 to 1.27	0.4 grams Interval 0.21 to 0.93

Adverse Events

Cryolipolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lilit Garibyan

Massachusetts General Hospital

Phone: 617-726-6168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place