Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

• The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
• Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
• Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 21
• 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: All

Description

Inclusion Criteria:

1. Able to read, understand and provide written Informed Consent;
2. Healthy adult, male or female, 18 years of age or older with skin type I-IV;
3. Having a suitable treatment area for hair removal;
4. Able and willing to comply with the treatment/follow-up schedule and requirements;
5. Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.

Exclusion Criteria:

1. Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
2. Hormonal disorders that may affect hair growth;
3. Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
4. Livedo reticularis;
5. Uncontrolled systemic diseases such as diabetes;
6. Active infections in the treated area;
7. Dysplastic nevi;
8. Significant concurrent skin conditions or any inflammatory skin conditions;
9. Active cold sores, open lacerations or abrasions;
10. Chronic or cutaneous viral, fungal, or bacterial diseases;
11. Current cancer;
12. History of skin cancer or pre-cancerous lesions at the treatment areas;
13. Use of Accutane™ (Isotretinoin) within the past six month;
14. Keloid formation in the treatment area;
15. Tattoos in the treatment area;
16. Bleeding coagulopathies or use of anticoagulants;
17. Auto-immune disorders;
18. Erythema ab igne, when identified treatments should be discontinued;
19. Photosensitivity disorder that can be exacerbated by laser or intense light;
20. Herpes simplex in the treatment area;
21. Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
22. Poor wound healing;
23. Sunburns;
24. Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation;
25. Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hair removal; hair removal treatment using 805nm LightSheer Duet HS handpiece	Device: LightSheer Duet HS handpiece; The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with Adverse Events	To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece	1 year
Hair count	To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece	6 monts follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's comfort using VAS	To evaluate subject's assessment of comfort associated with treatments	Baseline, 4, 8, 12, 16 weeks;
Asses subject's perception of improvement and satisfaction	To evaluate subject's satisfaction with hair removal treatments and assessment of improvement using subject's questionnaire	8, 16 weeks following baseline; 3 and 6 monts follow up

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: Suzanne Kilmer, MD, Laser & Skin Surgery Medical Group, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (ESTIMATE): February 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: LUM-ABU-HS 805nm-12-01