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About
Skin ageing is intricately linked to collagen degradation caused by internal and external factors. External factors contributing to ageing include ultraviolet rays, smoking, heat, and air pollution, and follow a distribution across the body according to the level of exposure. Whereas internal ageing occurs as a natural consequence of physiological changes over time. As we age, both natural internal and external factors cause stress to the body. This stress damages important molecules in our skin, including proteins, fats (lipids), and DNA. One of the main proteins affected is collagen, which gives skin its strength and firmness. This loss of collagen leads to visible signs of aging such as wrinkles, thinner skin (atrophy), rough or damaged texture (elastosis), and uneven skin tone (dyschromia).
Interventions such as collagen stimulators have shown promising outcomes in stimulating cells to produce collagen, thereby improving skin elasticity and firmness. Poly-L-Lactic Acid is a biodegradable long-chain polymer of repeating units of lactic acid derived from alpha-hydroxy acid. Injecting PLLA into the deep dermis or subcutaneous tissue, stimulates collagen production through an inflammatory response, resulting in skin rejuvenation that can last between two to three years. In contrast, CaHA-R drives the regeneration of collagens, elastin, and proteoglycans with minimal immune cell recruitment and immediate volume improvement lasting around 12-18 months. To date, there have been no randomized-controlled-trials comparing the efficacy of PLLA vs CaHa-R for skin rejuvenation in the face and body.
Enrollment
Sex
Ages
Volunteers
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:
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:
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.
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.
Participation in any interventional clinical study within 30 days of screening.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 2 patient groups
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Central trial contact
Laura Raco
Data sourced from clinicaltrials.gov
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