Laser hair removal in subjects with tan to dark skin types.
TRIAL DESIGN
This is a clinical trial to evaluate the skin response and level of comfort following treatment using the investigational LightSheer Duet 1060nm laser device in Fitzpatrick IV-VI and tanned skin types. A maximum of eighteen (18) participants will be enrolled in this study.
Participants that meet the inclusion criteria will be enrolled in the study and attend an initial screening visit to determine eligibility and review their medical history. Participants will receive one test spot treatment with the study device and return for 2 follow-up visits (30+/- hours and 7 +/-day) to assess safety of the treatment area.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be entered into the study:
- Able to read, understand and provide written Informed Consent including a photo release and skin biopsy consents;
- Healthy adult, male or female, 18 years of age or older with skin type IV-VI;
- Having at least one large suitable treatment area (able to contain 8 treatment spots) with dark brown or black hair;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Women of child bearing age are required to be using a reliable method of birth control at least 3 months prior to enrollment and throughout the course of the study.
Exclusion Criteria
Any of the following will exclude the subject from the study:
- 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;
- Treatment should not be attempted on patients with a history of skin cancer or pre-cancerous lesions at the treatment areas;
- Use of Accutane™ (Isotretinoin) within the past 6 months;
- 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 6 months prior to study enrollmentor during the course of the study.
If you feel that you may meet the qualifications please respond via email: study@skinlasers.com
Please contact Julie, our Study Coordinator, via email only. Study Email: study@skinlasers.com

















