Safety and Efficacy of Injectable Poly-L-Lactic Acid for Volume Loss in the Temples Using Dual Plane Injections

Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples.

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 authorizationHealthy males or females over 25 years old with temporal hollows volume deficit of Grade 2 to 4 on the Galderma Temple Volume Deficit ScaleSubjects with Fitzpatrick photo skin types I-IVSubjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, intense-pulsed light, ultrasound) for the duration of the studySubjects who do agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the studySubjects who understand this study and are able to follow study instructions and are willing to attend the required study visitsSubjects 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 pregnancySubjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, intrauterine device, 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 studySubjects who have a known allergy to poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol or any anestheticSubjects who have taken any NSAIDs (aspirin, ibuprofen, etc.) within 7 days before treatmentSubjects who have taken acetaminophen 24 hours before treatmentSubjects who have had fillers or botulinum toxin in the treatment area in the past 12 monthsSubjects who have had treatments with poly-L-lactic acid in the face at any timeSubjects 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 studySubjects 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 areaSubjects who have an active inflammatory process (skin eruptions such as cysts, pimples, rashes or hives) or infection within the treatment areaSubjects 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 studySubjects with a known history of poor wound healingSubjects with a known history of keloids (excessive scarring)Subjects who are HIV positiveSubjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the studySubjects who have participated in another research study in the past 30 daysSubjects who are currently involved in any injury litigation claims