Poly-L-lactic Acid for Skin Quality

Inclusion Criteria:

- Subjects who are able to give voluntary, written informed consent to participate in
this 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 facial
wrinkles

- 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 are
willing to attend the required study visits

- Subjects who agree to be photographed for research reasons and their identity may not
be concealed in these photographs.

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