PLLA and CaHA-R for Aesthetic Rejuvenation

Inclusion criteria

• Ability to adequately understand the verbal explanations and the written participant information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
• Participant with mild to severe skin irregularities in the bilateral cheeks and the décolletage region at baseline as assessed by both the Blinded Evaluator and Investigator (scores may differ) using the Galderma Decolletage Scale (GDS) and the Facial Laxity Rating (FLR) scale
• Immune-competent adult pre-menopausal women 21 years of age and older.
• Has intent to undergo treatment to improve appearance of the cheeks and décolletage.
• Could benefit from injectable treatment to improve appearance of the cheeks and the décolletage, in the opinion of the Treating Investigator.
• If the participant is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at Baseline and prior to receiving any study treatment.

Acceptable forms of effective birth control include:

• Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical caps) with spermicidal foam/gel/film/ cream/suppository;
• Bilateral tubal ligation;
• Combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
• Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
• Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
• Strict abstinence (at least one month prior to baseline and agrees to continue for the duration of the study or use acceptable form of birth control).
• Negative UPT for women of childbearing potential at the Baseline visit.
• Participant agrees to use the same topical cosmetic products (e.g., cleansers, moisturizers, SPF) throughout the duration of the trial, and at least for 30 days prior to enrolment.

Exclusion criteria

• Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
• Hypersensitivity to RADIESSE, or CaHA-R-based fillers.
• Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.
• Previous or present severe or multiple allergies, such as anaphylaxis or angioedema, or family history of these conditions.
• Previous surgery in or near the treatment area, including but not limited to liposuction.
• Previous treatment/procedure in or near the treatment area:

• Previous permanent implant, lifting threads in the treatment area, regardless of time.
• Previous semi-permanent implants exemplified by CaHA-R, PLLA in treatment area, within the last 18 months of screening.
• Previous hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months of screening.
• Previous energy-based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency, HIFEM and endermologie) in the treatment area within 6 months of screening.
• Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. medical chemical peel) in the treatment area within 6 months of screening.
• Previous treatment with cryolipolysis, lipolytic treatments, ultrasound treatment, carboxytherapy or liporeduction massage in the treatment area within 6 months of screening.
• Previous collagenase clostridium histolyticumaaes treatment within 6 months of screening OR is planning to undergo any of these procedures affecting the treatment area, at any time during the study.
• History of cancer or previous radiation near or on the area to be treated.
• Heavy smokers, classified as smoking more than 12 cigarettes per day.
• Presence of any active disease or lesions near or on the area to be treated, e.g.

• Inflammation, active or chronic infection in or near the treatment area
• Psoriasis, eczema, herpes zoster and acanthosis
• Cancer or precancerous condition (e.g. actinic keratosis)
• Severe skin laxity, flaccidity, or sagging
• Advanced photoaged/ photodamaged skin (e.g., advanced skin elastosis, multiple lentigo solaris lesions) or skin condition (e.g., very crinkled, very thin, fragile skin or severe skin atrophy) in the treatment area that in the Investigator's opinion could interfere with the safety or effectiveness of the study product or injection procedure.
• Evidence of scar-related disease or delayed healing activity within 1 year prior to the baseline visit, or participants susceptible to keloid formation, or hypertrophic scarring from injectable procedures.
• Skin coloring/bleaching/tattoo in the treatment area, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
• Intends to initiate a weight loss program during the study (e.g., restrictive diets, GLP-1 agonists).
• An underlying known disease, a surgical or medical condition that would expose the participant to undue risk, e.g. history of bleeding disorders, active hepatitis, active autoimmune disease such as connective tissue diseases, systemic lupus erythematosus, polymyositis, dermatomyositis, multiple sclerosis or scleroderma.
• Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g., warfarin, clopidogrel, aspirin, baby aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs)), Omega 3 or Vitamin E), within 14 days prior to injection. Omega 3 and Vitamin E are acceptable only as part of a standard multivitamin formulation. Cyclooxygenase-2 (COX 2) inhibitors are allowed.
• Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).
• Use of hormonal replacement therapy (HRT) unless the participant has been on a stable dose for at least 3 months prior to screening and does not plan to make any changes to the HRT regimen during the study period.
• Use of topical corticosteroids, topical prescription retinoids in the treatment area within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the baseline visit, or plan to receive such treatment.
• Pregnancy (confirmed by positive urine pregnancy test (UPT)/ serum pregnancy test), breast feeding or intends to become pregnant over the duration of the study.
• Presence of any condition or situation, which in the opinion of the Treating Investigator makes the Participant unable to complete the study per protocol, e.g.

• Participant is not likely to avoid other prohibited aesthetic treatments;
• Participant is not likely to complete the study because of other commitments;
• Participant is anticipated to be unavailable for visits, incapable of understanding the investigational assessments or having unrealistic expectations of treatment result;
• Participant who has a concomitant condition (e.g., acute viral or bacterial infection with fever) that might confuse or confound study treatments or assessments.
• Participation in any interventional clinical study within 30 days of screening.