Hair Removal Clinical Trial
Official title:
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
Verified date | August 2014 |
Source | Lumenis Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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.
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 Accutaneâ„¢ (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. |
Country | Name | City | State |
---|---|---|---|
United States | Laser & Skin Surgery Medical Group Inc | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Lumenis Ltd. |
United States,
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 |
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