Poly-L-lactic Acid for Skin Quality

Inclusion Criteria:

• Subjects who are able to give voluntary, written informed consent to participate inthis study and from whom consent has been obtained including HIPAA authorization

• Healthy females between 30 and 60 years of age

• Subjects with Fitzpatrick photo skin types I-IV

• Subjects with shallow to deep nasolabial fold contour deficiencies or other facialwrinkles

• Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler,botulinum toxin, radiofrequency, laser, IPL, ultrasound) for the duration of the study

• Subjects who do agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the study

• Subjects who understand this study and are able to follow study instructions and arewilling to attend the required study visits

• Subjects who agree to be photographed for research reasons and their identity may notbe concealed in these photographs.

Exclusion Criteria:

• Subjects who are pregnant, planning to become pregnant or breastfeeding. A urinepregnancy test will be done to rule out pregnancy

• Subjects of child-bearing potential who are not using an approved method of birthcontrol (oral contraceptives, IUD, contraceptive implant, barrier methods withspermicide or abstinence). Females of non-childbearing potential are defined aspost-menopausal (absence of menstrual bleeding for one year), hysterectomy orbilateral oophorectomy.

• Subjects who cannot understand or are not willing to comply with the requirements ofthe 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 beforetreatment

• Subjects who have taken acetaminophen 24 hours before treatment

• Subjects who have had fillers or botulinum toxin in the treatment area in the past 12months

• 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 IPLtreatment including superficial treatments for aesthetic reasons in the past 6 monthsor for the duration of the study

• Subjects who does not agree to avoid using tanning beds or intensive exposure to thesun 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 thetreatment 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 theduration 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 mayput 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