Trial Outcomes & Findings for Silk'n HST Device Usability and Self Selection Study (NCT NCT02919007)

Results Overview

Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

1 hour

Results posted on

2018-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Silk'h HST Treatment Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual. Silk'h HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Silk'n HST Device Usability and Self Selection Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silk'h HST Treatment n=25 Participants Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual. Silk'h HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	49.2 years STANDARD_DEVIATION 15.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.

Outcome measures

Outcome measures
Measure	Silk'n HST Treatment n=25 Participants Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual. Silk'n HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual
Usability Assessment	25 Participants

Adverse Events

Silk'h HST Treatment

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 Liora Levi

Home Skinovations

Phone: +97249097470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place