Status:
COMPLETED
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
Lead Sponsor:
Lumenis Be Ltd.
Conditions:
Hair Removal
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Able to read, understand and provide written Informed Consent;
- Healthy adult, male or female, 18 years of age or older with skin type I-IV;
- Having a suitable treatment area for hair removal;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- 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
- Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months);
- Hormonal disorders that may affect hair growth;
- Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- Livedo reticularis;
- Uncontrolled systemic diseases such as diabetes;
- Active infections in the treated area;
- Dysplastic nevi;
- Significant concurrent skin conditions or any inflammatory skin conditions;
- Active cold sores, open lacerations or abrasions;
- Chronic or cutaneous viral, fungal, or bacterial diseases;
- Current cancer;
- History of skin cancer or pre-cancerous lesions at the treatment areas;
- Use of Accutane™ (Isotretinoin) within the past six month;
- Keloid formation in the treatment area;
- Tattoos in the treatment area;
- Bleeding coagulopathies or use of anticoagulants;
- Auto-immune disorders;
- Erythema ab igne, when identified treatments should be discontinued;
- Photosensitivity disorder that can be exacerbated by laser or intense light;
- Herpes simplex in the treatment area;
- Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
- Poor wound healing;
- Sunburns;
- 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;
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01801202
Start Date
February 1 2013
End Date
November 1 2014
Last Update
April 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Laser & Skin Surgery Medical Group Inc
Sacramento, California, United States, 95816