Trial Outcomes & Findings for Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair (NCT NCT01912950)
NCT ID: NCT01912950
Last Updated: 2023-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
12-weeks
Results posted on
2023-02-21
Participant Flow
Unit of analysis: areas on the forearm
Participant milestones
| Measure |
All Study Participants
Each subject will receive hair removal treatments with the Prowave LX IPL. Each subject will have one designated treatment area on the foreman and one un-treated control area.
|
|---|---|
|
Overall Study
STARTED
|
11 22
|
|
Overall Study
Treated Areas on the Forearm
|
11 11
|
|
Overall Study
Untreated Areas on the Forearm
|
11 11
|
|
Overall Study
COMPLETED
|
7 14
|
|
Overall Study
NOT COMPLETED
|
4 8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=11 Participants
All enrolled subjects receiving treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-weeksOutcome measures
| Measure |
Prowave LX IPL
n=7 Participants
Treatment with Prowave LX IPL
|
No Treatment
n=7 Participants
No treatment administered
|
|---|---|---|
|
Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment
|
41 percent reduction
Interval -62.0 to 97.0
|
27 percent reduction
Interval -60.0 to 85.0
|
Adverse Events
Prowave LX IPL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
No 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
| Measure |
Prowave LX IPL
n=11 participants at risk
Prowave LX IPL on one area of the forearm
|
No Treatment
n=11 participants at risk
No treatment administered.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
45.5%
5/11 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Edema
|
9.1%
1/11 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place