Poly-L-lactic Acid for Skin Quality

Exclusion Criteria

• •Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy
• •Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
• •Subjects who cannot understand or are not willing to comply with the requirements of the study
• •Subjects who have a known allergy to poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol or any anesthetic
• •Subjects who have taken any NSAIDs (aspirin, ibuprofen, etc.) within 7 days before treatment
• •Subjects who have taken acetaminophen 24 hours before treatment
• •Subjects who have had fillers or botulinum toxin in the treatment area in the past 12 months
• •Subjects who have had treatments with poly-L-lactic acid in the face at any time
• •Subjects who have had any kind of facial dermabrasion, chemical peel, laser, or IPL treatment including superficial treatments for aesthetic reasons in the past 6 months or for the duration of the study
• •Subjects who does not agree to avoid using tanning beds or intensive exposure to the sun 2 two weeks prior to each office visit.
• •Subjects who have any dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection or scars within the treatment area
• •Subjects who have an active inflammatory process (skin eruptions such as cysts, pimples, rashes or hives) or infection within the treatment area
• •Subjects who have any known cancer including skin cancers (basal cell carcinoma, squamous cell carcinoma and melanoma)
• •Subjects who have had systemic corticosteroid therapy in the past 6 months or for the duration of the study
• •Subjects with a known history of poor wound healing
• •Subjects with a known history of keloids (excessive scarring)
• •Subjects who are HIV positive
• •Subjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the study
• •Subjects who have participated in another research study in the past 30 days
• •Subjects who are currently involved in any injury litigation claims