Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

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.

Study Overview

• Status: Completed
• Conditions: Hair Removal
• Intervention / Treatment: Device: LightSheer Duet

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS treatment; Treatment with HS handpiece	Device: LightSheer Duet; LightSheer Duet HS handpiece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month following last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Each treatment
Level of Comfort Associated With Treatment		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.	15 month following last treatment

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 9, 2011
• First Submitted That Met QC Criteria: January 23, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: LUM- ABU-LSDuet-08-001