Pilot Evaluation of Smart vs HERO Broadband Light Treatment for Pigmented Skin Lesions

Exclusion Criteria

• •Fitzpatrick skin type IV-VI
• •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• •Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
• •Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
• •History of malignant tumors in the target area.
• •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
• •Pregnant and/or breastfeeding.
• •Having an infection, dermatitis or a rash in the treatment area.
• •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
• •Suffering from coagulation disorders or taking prescription anticoagulation medications.
• •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• •History of vitiligo, eczema, or psoriasis.
• •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• •History of seizure disorders due to light.
• •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
• •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• •Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
• •Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the target area within 1 month of participation.
• •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• •Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
• •Current smoker or history of smoking within 6 months of study participation.