Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic)
Sponsored by Sadick Research Group
About this trial
Last updated 4 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
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 an males between 30 and 65 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