Trial Outcomes & Findings for Clinical Evaluation of Silk'n Glide for Face (NCT NCT02103608)
NCT ID: NCT02103608
Last Updated: 2018-09-10
Results Overview
Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
4 weeks and 12 weeks post treatment
Results posted on
2018-09-10
Participant Flow
Participant milestones
| Measure |
Glide Device
Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Glide Device
n=17 Participants
Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=17 Participants
|
|
Hair count at baseline
|
22.7 hair strands/cm^2
STANDARD_DEVIATION 14.6 • n=17 Participants
|
PRIMARY outcome
Timeframe: 4 weeks and 12 weeks post treatmentPopulation: Individuals who could benefit from hair reduction
Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated.
Outcome measures
| Measure |
Glide Device
n=15 Participants
Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
|
|---|---|
|
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
4 weeks follow up
|
83.3 percentage of hair reduction
Standard Deviation 22.5
|
|
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
12 weeks follow up
|
78.1 percentage of hair reduction
Standard Deviation 34.2
|
Adverse Events
Glide Device
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place