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

Lumenis

Status: Completed

Conditions: Laser Hair Removal

Study type: Observational

Funder types: Industry

Identifiers

NCT00657085

LUM-ABU-HSET-0607-02

Details and patient eligibility

About

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

Enrollment: 5 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.