Trial Outcomes & Findings for Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types VI Using Intense Pulsed Light (NCT NCT02452398)
NCT ID: NCT02452398
Last Updated: 2020-11-03
Results Overview
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
6 months after last treatment
Results posted on
2020-11-03
Participant Flow
The study was terminated and no results analysis was done.
Participant milestones
| Measure |
Treatment Group
Hair removal treatment using Venus Versa IPL energy
Venus Versa: The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures.
The device consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated. The applicator that will be used for this study (HR 690) has a wavelength of 690 nm and has a spot size (treatment area) of 30 mm by 10 mm.
IPL gel: water based gel used to protect the skin during light based treatments. Also used during ultrasound treatments.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Treatment Group
Hair removal treatment using Venus Versa IPL energy
Venus Versa: The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures.
The device consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated. The applicator that will be used for this study (HR 690) has a wavelength of 690 nm and has a spot size (treatment area) of 30 mm by 10 mm.
IPL gel: water based gel used to protect the skin during light based treatments. Also used during ultrasound treatments.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
28
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Moved away
|
4
|
Baseline Characteristics
Data were not collected.
Baseline characteristics by cohort
| Measure |
Hair Removal With Versa HR 690nm Applicator
n=79 Participants
Subjects with Fitzpatrick skin type V-VI requesting hair removal (right and left axillae and double sided bikini line) or one double sided large area (right and left thighs) or one large area (whole back / abdomen).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=79 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=79 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=79 Participants
|
|
Sex/Gender, Customized
Unknown
|
79 Participants
n=79 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
79 Participants
n=79 Participants
|
|
Hair count in marked treatment area
|
0 Participants
Data were not collected.
|
PRIMARY outcome
Timeframe: 6 months after last treatmentPopulation: This primary outcome measurement could not be reported as data were not collected.
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
Outcome measures
Outcome data not reported
Adverse Events
Hair Removal With Versa HR 690nm Applicator
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