A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing

Exclusion Criteria

• •1. Pregnant, breastfeeding, or planning to become pregnant during the study.
• •2. History of any type of allergic reaction to topical anesthetics.
• •3. Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
• •4. Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
• •5. Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
• •6. Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
• •7. Predisposition to keloid formation or excessive scarring.
• •8. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
• •9. Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
• •10. Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study.
• •11. Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
• •12. Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
• •13. Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment.
• •14. Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study.
• •15. Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.
• •16. Sunburn and/or significant recent sun exposure on the target treatment zone in the last 2 weeks prior to enrollment that, according to investigator judgement, would impact treatment, and/or unwilling to practice photoprotection and/or avoid significant sun exposure for the duration of study participation.