Histologic Evaluation of Tissue Following Lutronic System Exposure

Exclusion Criteria

• •1. Poorly controlled medical condition that could compromise wound healing or increase risk of infection such as an impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, or chemotherapy.
• •2. Subjects with sensitivity or allergy to gold.
• •3. Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
• •4. Subjects with current skin cancer or other malignant disease including pre-malignant moles.
• •5. History of vascular disease.
• •6. History of bleeding disorders.
• •7. History of skin disorders, keloid scarring, and/or abnormal wound healing.
• •8. Presence of an active skin condition or infection in the exposure area such as sores, Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex breakout.
• •9. Open wounds or lesions in the exposure area.
• •10. Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the exposure area, and other implantable devices or synthetic fillers within the exposure area.
• •11. History of seizure disorders due to light (Group D).
• •12. History of vitiligo, eczema, or psoriasis (Group D).
• •13. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation (Group D).
• •14. Excessive or recent significant tan in areas of test spot exposure (Group D).
• •15. Inability to understand the protocol or to give informed consent.
• •16. History of chronic drug or alcohol abuse.
• •17. Concurrent enrollment in any study involving the use of investigational devices or drugs.
• •18. History of surgical or cosmetic treatments in exposure area within the past six months.
• •19. History or current use of the following medications:
• •1. Daily anticoagulants, aspirin, iron supplements, herbal supplements or ointments such as ginkgo, ginseng or garlic;
• •2. Topical retinoid in the exposure area within the past one week; and Protocol Number: L18006 v5.0 11192018 Page 9 of 52
• •3. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
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