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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Sculptra® Aesthetic is manufactured by Galderma Laboratories. It is a sterile, lyophilized preparation of PLLA that is biocompatible and biodegradable. Each vial contains 367.5 mg of freeze-dried powder, including 150 mg of PLLA. Prior to injection, it will be reconstituted with sterile water for injection (SWFI) and lidocaine hydrochloride (2%). For this study, commercial products will be used. The study products are for single use only.
Radiesse® is manufactured by Merz Aesthetics. It is a sterile, non-pyrogenic, semi-solid injectable implant composed of synthetic CaHA suspended in a gel carrier of sterile water, glycerin, and sodium carboxymethylcellulose. Each pre-filled syringe contains 1.5 mL of product. The product includes 0.3% lidocaine for pain reduction during injection. For this study, commercial products will be used. The study products are for single use only.
Erevna Innovations Inc.
Montreal, Quebec, Canada
RECRUITINGChange in Skin Elasticity Measured by Cutometer
Change in skin elasticity parameters (net elasticity, gross elasticity, distensibility, and maximum recovery) will be measured using the Cutometer Dual MPA 580 on the cheek and décolleté.
Time frame: Baseline (Visit 1) to Week 40 (Visit 6)
Participant Satisfaction with Treatment
Participant satisfaction will be assessed using a 7-point Likert scale questionnaire rating satisfaction with skin appearance after treatment (from "Very Dissatisfied" to "Very Satisfied"). Scores will be compared between groups.
Time frame: Week 20 (Visit 4), Week 30 (Visit 5), and Week 40 (Visit 6)
Global Aesthetic Improvement Scale (GAIS) as Assessed by a Blinded Evaluator
Blinded evaluators will assess aesthetic improvement using the GAIS. The percentage of participants rated as at least "Improved" ("Improved", "Much Improved", or "Very Much Improved") compared to Baseline will be compared between groups
Time frame: Baseline, Week 20 (Visit 4), Week 30 (Visit 5), Week 40 (Visit 6)
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