Comparing Sculptra Aesthetic with Radiesse for aesthetic

Exclusion

• −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.
• −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.
• −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −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.
• −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 visitBaselineYour starting measurements, taken before treatment begins.Read more →, 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).
• −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.
• −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.
• −Presence of any condition or situation, which in the opinion of the Treating Investigator makes the Participant unable to complete the study per protocolProtocolThe detailed plan a study must follow.Read more →, 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 interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study within 30 days of screening.
• −Pregnancy (confirmed by positive urine pregnancy test (UPT)/ serum pregnancy test), breast feeding or intends to become pregnant over the duration of the study.
• −Previous surgery in or near the treatment area, including but not limited to liposuction.
• −History of cancer or previous radiation near or on the area to be treated.
• −Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).
• −Heavy smokers, classified as smoking more than 12 cigarettes per day.