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CompletedNCT01282866Updated Oct 21, 2016Results posted

Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

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

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Hair Removal
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult, female, 18 years of age or older with skin type I-IV;
  2. Having at least one suitable treatment area for hair removal with brown hair;
  3. Able and willing to comply with the treatment/follow-up schedule and requirements;
  4. Able to read, understand and provide written Informed Consent.
  5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.

Exclusion criteria

Exclusion Criteria:

  1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
  2. Use of oral isotretinoin (Accutane®) within 6 months
  3. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
  4. History of keloid formation or poor wound healing in a previously injured skin area;
  5. Significant skin conditions affecting treated area or inflammatory skin conditions;
  6. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
  7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
  8. Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;
  9. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated, personal history of melanoma;
  10. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
  11. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
  12. Tattoos in the treatment areas;
  13. Dysplastic nevi in the treatment areas;
  14. Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
  15. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  16. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;
  17. Allergy or history of an allergy to any topical anesthetic used;
  18. Pregnant, expectation of pregnancy, postpartum (\<3 months) or nursing (\<6 weeks);
  19. History of livedo reticularis, an autoimmune vascular disease;
  20. Hypersensitivity at the treatment site to any agents, solutions, or gel used in the treatment (applies to ET handpiece only), if no alternative exists;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    HS treatment

    Treatment with HS handpiece

    Device: LightSheer Duet

Interventions

  • DeviceLightSheer Duet

    LightSheer Duet HS handpiece

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Level of Comfort Associated With Treatment

    Time frame: Each treatment

  3. 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

07

Results

Posted Apr 3, 2014

Participant flow

Participant flow — Overall Study
MilestoneHS Treatment
Started35
Completed34
Not completed1
Withdrew: Adverse event1

Outcome measures

PrimaryHair 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
Reported as:
Mean · percentage of hair clearance
Hair Count
percentage of hair clearanceHS Treatment
Hair Count54 ± 24
Statistical analysis
  • HS Treatment · t-test, 2 sided · p = <0.001
SecondaryTreatment 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
Reported as:
Mean · minutes
Treatment Time
minutesHS Treatment
Treatment Time3.5 ± 2.7
SecondaryLevel of Comfort Associated With Treatment
Time frame:
Each treatment

Results for this outcome have not been posted.

SecondaryHair 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
Reported as:
Mean · percentage of hair clearance
Hair Count
percentage of hair clearanceHS Treatment
Hair Count42 ± 25

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HS Treatment—1/35 (2.9%)0/35 (0%)
Most frequent serious events
Most frequent serious events
EventHS Treatment
injured ankleMusculoskeletal and connective tissue disorders1/35

Baseline characteristics

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
Age, Continuous(years)HS Treatment
Mean30.9 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)HS Treatment
Female35
Male0
Region of Enrollment
Region of Enrollment(participants)HS Treatment
United States35
08

Study locations

1 site
  • Laser & Skin Surgery Medical Group Inc
    Sacramento, California 95816, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01282866
Lead sponsor
Lumenis Be Ltd.
Responsible party
Sponsor
First posted
Jan 25, 2011
Start date
Jun 2009
Primary completion
Nov 2011
Completion
Nov 2011
Results posted
Apr 3, 2014
Last update
Oct 21, 2016
View the source record on ClinicalTrials.gov ↗

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