Efficacy and Safety of PiQo4 Device for Treatment of Melasma

Exclusion Criteria

• •1. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
• •2. Known hypersensitivity or contraindications to anaesthetic agents including lidocaine and its derivatives
• •3. Participation in a study of another device or drug within three months prior to enrolment or during the study.
• •4. Presence of open wounds or lesions in the area
• •5. Extensive scarring or tattoos in areas to be treated.
• •6. Having other pigmentation disorder
• •7. Having an excessive underlying vascular condition (e.g. dense network of capillaries).
• •8. 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.
• •9. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• •10. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen
• •11. Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area
• •12. Laser or medium/deep chemical peel, or surgery, or filler treatments using collagen, hyaluronic acid, or any other material at area of treatment, within 6 months of initial treatment or during the course of the study.
• •13. IPL or superficial chemical peel within the previous 1 month
• •14. Topical therapy with retinoids, imiquimod, 5-fluorouracil, ingenol mebutate, diclofenac, alpha-hydroxy acids, or salicylic acids within the previous 1 month.
• •15. Currently using topical retinoid, hydroquinone or corticosteroid or whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks
• •16. Lightening oral medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months
• •17. History of keloid scarring, hypertrophic scarring, or of abnormal wound healing.
• •18. History of connective tissue diseases such as systemic lupus erythematosus or scleroderma
• •19. Active leukoplakia, eczema, or psoriasis in the treatment area
• •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 in the treatment area
• •24. Significant concurrent illness or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
• •25. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• •26. Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion).
• •27. History of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive)
• •28. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study