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

NCT ID: NCT00657085

Last Updated: 2008-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-12-31

Brief Summary

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

Conditions

Laser Hair Removal

Keywords

Laser hair removal

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Lumenis

Principal Investigators

Seaver Soon, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Dermatology

Locations

Seaver Soon

San Diego, California, United States

Countries

United States

Other Identifiers

LUM-ABU-HSET-0607-02

Identifier Type: -

Identifier Source: org_study_id