Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Hair Removal Clinical Trial

Official title:

Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801202
• Other study ID #: LUM-ABU-HS 805nm-12-01
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: April 28, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2014
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hair Removal

Intervention

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).

Locations

Country	Name	City	State
United States	Laser & Skin Surgery Medical Group Inc	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with Adverse Events	To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece	1 year
Primary	Hair count	To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece	6 monts follow up
Secondary	Subject's comfort using VAS	To evaluate subject's assessment of comfort associated with treatments	Baseline, 4, 8, 12, 16 weeks;
Secondary	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