Hair Removal
Conditions
Brief 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.
Interventions
DEVICELightSheer Duet
LightSheer Duet HS handpiece
Sponsors
Lumenis Be Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Count | 6 month following last treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Time | Each treatment | 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. |
| Level of Comfort Associated With Treatment | Each treatment | — |
| Hair Count | 15 month following last treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HS Treatment Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm\^2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | HS Treatment |
|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 1 / 35 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HS Treatment | Hair Count | 54 percentage of hair clearance | Standard Deviation 24 |
p-value: <0.001t-test, 2 sided
Secondary
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
Population: The number of participants who completed 15 months follow up was 23 out of 35.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HS Treatment | Hair Count | 42 percentage of hair clearance | Standard Deviation 25 |
Secondary
Level of Comfort Associated With Treatment
Time frame: Each treatment
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HS Treatment | Treatment Time | 3.5 minutes | Standard Deviation 2.7 |