Trial Outcomes & Findings for The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design (NCT NCT01348776)
NCT ID: NCT01348776
Last Updated: 2013-04-04
Results Overview
Hair clearance = the percent of hair cleared from baseline to endpoint.
COMPLETED
NA
87 participants
3 months (1 month after 7 weekly treatments)
2013-04-04
Participant Flow
The recruitment was conducted in a medical clinic. The recruitment continued from April to October 2011.
3 subjects were found not eligible and 1 withdrew the informed consent before beginning treatments.
Participant milestones
| Measure |
Hair2Go (Me)
Subjects treated with the Hair2Go (Me) Device
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Hair2Go (Me)
Subjects treated with the Hair2Go (Me) Device
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
Baseline characteristics by cohort
| Measure |
Hair2Go (Me)
n=87 Participants
Subjects treated with the Hair2Go (Me) Device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
36.4 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months (1 month after 7 weekly treatments)Population: Sample size was discussed with the FDA during a pre-IDE meeting.
Hair clearance = the percent of hair cleared from baseline to endpoint.
Outcome measures
| Measure |
Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)
n=143 areas of treatment
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
|
Hair2Go (Mē) no Maintenance Side
n=143 areas of treatment
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
|
Treatment #7
Self assessment of tolerability level of procedure during 7th treatment
|
Maintenance Treatment #3
Self assessment of tolerability level of procedure during 3rd maintenance treatment
|
|---|---|---|---|---|
|
Hair Clearance 1 Month After Last Treatment
|
56.83 %baseline hair count
Standard Deviation 42.96
|
54.08 %baseline hair count
Standard Deviation 41.21
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 months (3 months after 7 weekly treatments)Population: All areas with photos that allowed reliable hair counting were included for this analysis.
Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.
Outcome measures
| Measure |
Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)
n=142 Treatment Areas
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
|
Hair2Go (Mē) no Maintenance Side
n=139 Treatment Areas
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
|
Treatment #7
Self assessment of tolerability level of procedure during 7th treatment
|
Maintenance Treatment #3
Self assessment of tolerability level of procedure during 3rd maintenance treatment
|
|---|---|---|---|---|
|
Hair Clearance at 3-month (Final) Follow up
|
58.3 %baseline hair count
Standard Error 37.4
|
44.2 %baseline hair count
Standard Error 38.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 19 weeksAs with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.
Outcome measures
| Measure |
Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)
n=2765 total treatments
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
|
Hair2Go (Mē) no Maintenance Side
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
|
Treatment #7
Self assessment of tolerability level of procedure during 7th treatment
|
Maintenance Treatment #3
Self assessment of tolerability level of procedure during 3rd maintenance treatment
|
|---|---|---|---|---|
|
Occurrence of Anticipated Effects on Skin
Erythema
|
20 Number of reports
|
—
|
—
|
—
|
|
Occurrence of Anticipated Effects on Skin
Pruritis
|
2 Number of reports
|
—
|
—
|
—
|
|
Occurrence of Anticipated Effects on Skin
Edema
|
2 Number of reports
|
—
|
—
|
—
|
|
Occurrence of Anticipated Effects on Skin
Inflammation
|
2 Number of reports
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable \[had to stop treatment\]) . The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated.
Outcome measures
| Measure |
Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)
n=332 Treatment areas analyzed
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
|
Hair2Go (Mē) no Maintenance Side
n=330 Treatment areas analyzed
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
|
Treatment #7
n=330 Treatment areas analyzed
Self assessment of tolerability level of procedure during 7th treatment
|
Maintenance Treatment #3
n=146 Treatment areas analyzed
Self assessment of tolerability level of procedure during 3rd maintenance treatment
|
|---|---|---|---|---|
|
Tolerability Level of the Procedure Following Treatments
No Pain
|
83.13 % treated areas
|
91.52 % treated areas
|
89.09 % treated areas
|
86.99 % treated areas
|
|
Tolerability Level of the Procedure Following Treatments
Mild Pain
|
13.86 % treated areas
|
8.48 % treated areas
|
8.48 % treated areas
|
11.64 % treated areas
|
|
Tolerability Level of the Procedure Following Treatments
Moderate Pain
|
3.01 % treated areas
|
0 % treated areas
|
2.42 % treated areas
|
1.37 % treated areas
|
|
Tolerability Level of the Procedure Following Treatments
Severe Pain
|
0 % treated areas
|
0 % treated areas
|
0 % treated areas
|
0 % treated areas
|
|
Tolerability Level of the Procedure Following Treatments
Intolerable (had to stop treatment)
|
0 % treated areas
|
0 % treated areas
|
0 % treated areas
|
0 % treated areas
|
SECONDARY outcome
Timeframe: 5 months (final follow up)Population: Two subjects did not report on satisfaction.
Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
Outcome measures
| Measure |
Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)
n=85 Participants
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
|
Hair2Go (Mē) no Maintenance Side
Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
|
Treatment #7
Self assessment of tolerability level of procedure during 7th treatment
|
Maintenance Treatment #3
Self assessment of tolerability level of procedure during 3rd maintenance treatment
|
|---|---|---|---|---|
|
Subject Satisfaction
Very satisfied
|
31 participants
|
—
|
—
|
—
|
|
Subject Satisfaction
Satisfied
|
33 participants
|
—
|
—
|
—
|
|
Subject Satisfaction
Slightly satisfied
|
9 participants
|
—
|
—
|
—
|
|
Subject Satisfaction
No opinion
|
4 participants
|
—
|
—
|
—
|
|
Subject Satisfaction
Unsatisfied
|
8 participants
|
—
|
—
|
—
|
Adverse Events
Hair2Go (Me)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hair2Go (Me)
n=87 participants at risk
Subjects treated with the Hair2Go (Me) Device
|
|---|---|
|
Skin and subcutaneous tissue disorders
Blister
|
1.1%
1/87 • Number of events 2 • 5 month - from 1st treatment to last follow up
|
|
Skin and subcutaneous tissue disorders
Severe Pain
|
2.3%
2/87 • Number of events 8 • 5 month - from 1st treatment to last follow up
|
Additional Information
Doran Rozen, Director of Clinical Affairs
Syneron Beauty
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60