Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

NCT ID: NCT01801202

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-11-30

Brief Summary

• 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.

Conditions

Hair Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hair removal

hair removal treatment using 805nm LightSheer Duet HS handpiece

Group Type: EXPERIMENTAL

LightSheer Duet HS handpiece

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne Kilmer, MD

Role: PRINCIPAL_INVESTIGATOR

Laser & Skin Surgery Medical Group, Inc.

Locations

Laser & Skin Surgery Medical Group Inc

Sacramento, California, United States

Countries

United States

Other Identifiers

LUM-ABU-HS 805nm-12-01

Identifier Type: -

Identifier Source: org_study_id