Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction

To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.

Study Overview

• Status: Completed
• Conditions: Laser Hair Removal

• Study Type: Observational
• Enrollment (Anticipated): 5

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States
      • Seaver Soon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

5 Adult male subjects that have sought laser back hair removal

Description

Inclusion Criteria:

1. Healthy male adult, 18 years of age or older with skin type I-V;
2. Having a suitable treatment area for hair removal with brown or black hair (no gray);
3. Able and willing to comply with the treatment/follow-up schedule and requirements;
4. Able to read, understand and provide written Informed Consent.

Exclusion Criteria:

1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
2. Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
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. Adverse reaction to the treatment gel to be used in the evaluation;
5. History of keloid formation or poor wound healing in a previously injured skin area;
6. Significant skin conditions affecting treated area or inflammatory skin conditions;
7. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
9. Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
10. 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;
11. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
12. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
13. Photosensitivity disorder that can be exacerbated by infrared light;
14. Tattoos in the treatment areas;
15. Dysplastic nevi in the treatment areas;
16. Allergy or history of an allergy to the topical anesthetic used.
17. Participation in a study of another device or drug within 3 months 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;
18. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
19. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Follicular damage assessed by histology	first visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of permanent hair reduction between ET and HS handpieces	2 month follow up visit

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: Seaver Soon, MD, Scripps Dermatology

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 11, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2008
• Last Update Submitted That Met QC Criteria: December 10, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Laser hair removal
• Other Study ID Numbers: LUM-ABU-HSET-0607-02