An interventional study of LightSheer Duet in Hair Removal, sponsored by Lumenis Be Ltd.. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment
The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.
Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with HS handpiece
Device: LightSheer Duet
LightSheer Duet HS handpiece
Hair Count
The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.
Time frame: 6 month following last treatment
Treatment Time
The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.
Time frame: Each treatment
Level of Comfort Associated With Treatment
Time frame: Each treatment
Hair Count
The hair at the treatment area is counted at Baseline and 15 months following the last treatment. Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.
Time frame: 15 month following last treatment
| Milestone | HS Treatment |
|---|---|
| Started | 35 |
| Completed | 34 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.
| percentage of hair clearance | HS Treatment |
|---|---|
| Hair Count | 54 ± 24 |
The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.
| minutes | HS Treatment |
|---|---|
| Treatment Time | 3.5 ± 2.7 |
Results for this outcome have not been posted.
The hair at the treatment area is counted at Baseline and 15 months following the last treatment. Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.
| percentage of hair clearance | HS Treatment |
|---|---|
| Hair Count | 42 ± 25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HS Treatment | — | 1/35 (2.9%) | 0/35 (0%) |
| Event | HS Treatment |
|---|---|
| injured ankleMusculoskeletal and connective tissue disorders | 1/35 |
The power calculation proposed a sample of 35 participants to be sufficient to obtain qualitative assessment of hair removal, as well as the qualitative assessment of treatment time and pain experienced during treatment with the LightSheer Duet HS handpiece.
| Age, Continuous(years) | HS Treatment |
|---|---|
| Mean | 30.9 ± 10 |
| Sex: Female, Male(Participants) | HS Treatment |
|---|---|
| Female | 35 |
| Male | 0 |
| Region of Enrollment(participants) | HS Treatment |
|---|---|
| United States | 35 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Lumenis Be Ltd.