Evaluation of the Effectiveness of the PiQo4 System for Reduction of Infra-orbital Pigmentation

Exclusion Criteria

• •1. Pregnant or breastfeeding
• •2. Inability to comply with all study protocols and regulations
• •3. Participation in a study of another device or drug
• •4. Heavy smokers and/or drinkers (those who smoke 25 or more cigarettes a day and/or ⩾8 drinks a week for women, and ⩾15 for men)
• •5. Application of any energy device treatment to the infraorbital region within 3 months
• •6. Application of any dermal filler to the infraorbital region within 6 months
• •7. Facial resurfacing, deep chemical peels, or taking oral retinoids within 6 months
• •8. Microdermabrasion (light or medium skin peel) treatment within 30 days
• •9. Chemical peel, systemic steroids, non-ablative laser, light, or radiofrequency treatment within 3 months
• •10. Use of topical lightening agents or retinoids within 14 days
• •11. Any planned surgical intervention to the face for the duration of the trial
• •12. Use of Latisse, Revitalash, or other lash enhancement stimulators as well as Bimatoprost in the previous 1 month
• •13. Presence of open wounds, lesions, or scarring in the area
• •14. Very thin skin (skin that tears, bruises, or breaks easily)
• •15. Suffering from current or history of significant skin conditions in the treated area that could interfere with the evaluation (i.e. infection, dermatitis, or rash on their face) or requires the use of interfering topical or systemic therapy.
• •16. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• •17. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex (HSV, HZO) in the treated area, unless treatment is conducted following a prophylactic regimen
• •18. History of keloid scarring, hypertrophic scarring, or of abnormal wound healing.
• •19. History of connective tissue diseases such as systemic lupus erythematosus or scleroderma
• •20. History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
• •21. History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
• •22. Has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present
• •23. History of skin cancer
• •24. Change of contraceptives dosing in the past 3 months
• •25. Medical disorders such as thyroid or kidney diseases
• •26. Significant concurrent illness or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
• •27. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study