Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Not Applicable

Completed

• Conditions: Hair Removal
• Interventions: Device: LightSheer Duet HS handpiece

• Registration Number: NCT01801202
• Lead Sponsor: Lumenis Be Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Status Verified: 2014-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hair removal	LightSheer Duet HS handpiece	hair removal treatment using 805nm LightSheer Duet HS handpiece

Primary Outcome Measures

Name	Time	Method
Hair count	6 monts follow up	To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece
Number of subjects with Adverse Events	1 year	To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece

Secondary Outcome Measures

Name	Time	Method
Subject's comfort using VAS	Baseline, 4, 8, 12, 16 weeks;	To evaluate subject's assessment of comfort associated with treatments
Asses subject's perception of improvement and satisfaction	8, 16 weeks following baseline; 3 and 6 monts follow up	To evaluate subject's satisfaction with hair removal treatments and assessment of improvement using subject's questionnaire

Trial Locations

Locations (1)

Laser & Skin Surgery Medical Group Inc; 🇺🇸 Sacramento, California, United States