Actively Recruiting
PLLA and CaHA-R for Aesthetic Rejuvenation
Led by Erevna Innovations Inc. · Updated on 2025-10-01
45
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
PLLA and CaHA-R for Aesthetic Rejuvenation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study information and willing to give informed consent
- Mild to severe skin irregularities on both cheeks and décolletage as measured by Galderma Decolletage Scale and Facial Laxity Rating scale
- Immune-competent adult pre-menopausal women aged 21 years and older
- Intends to have treatment to improve cheeks and décolletage appearance
- May benefit from injectable treatment for cheeks and décolletage per investigator
- Women of childbearing potential agree to use effective birth control during study and take urine pregnancy tests at baseline and before treatment
- Negative urine pregnancy test at baseline for women of childbearing potential
- Will use same topical cosmetic products consistently during trial and 30 days prior to enrollment
You will not qualify if you...
- Allergy or hypersensitivity to any Sculptra components
- Allergy or hypersensitivity to Radiesse or CaHA-R fillers
- Allergy to lidocaine or other local anesthetics
- History of severe or multiple allergies including anaphylaxis or angioedema
- Prior surgery near treatment area, including liposuction
- Previous permanent implants or lifting threads in treatment area
- Semi-permanent implants like CaHA-R or PLLA in treatment area within last 18 months
- Hyaluronic acid or collagen filler in treatment area within last 12 months
- Energy-based aesthetic procedures in treatment area within last 6 months
- Mechanical or chemical aesthetic procedures in treatment area within last 6 months
- Cryolipolysis, lipolytic, ultrasound, carboxytherapy, or liporeduction massage in treatment area within last 6 months
- Collagenase clostridium histolyticum treatment within last 6 months or planned during study
- History of cancer or radiation near treatment area
- Heavy smoking (more than 12 cigarettes daily)
- Active disease or lesions near treatment area including infections, psoriasis, eczema, cancer, severe skin laxity, advanced photodamaged skin
- Scar-related disease or delayed healing within 1 year or susceptibility to keloids or hypertrophic scars
- Skin coloring, bleaching, or tattoos in treatment area affecting injections or assessments
- Plans to start weight loss program during study
- Known diseases or conditions posing undue risk such as bleeding disorders, active hepatitis, autoimmune diseases
- Use of medications prolonging bleeding within 14 days before injection except certain allowed drugs
- Recent chemotherapy, immunosuppressants, or systemic corticosteroids within 3 months
- Unstable hormonal replacement therapy or planned changes during study
- Use of topical corticosteroids or prescription retinoids in treatment area within 1 month or systemic retinoids within 6 months
- Pregnancy, breastfeeding, or intent to become pregnant during study
- Any condition that may prevent study completion or compliance
- Participation in other interventional clinical studies within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erevna Innovations Inc.
Montreal, Quebec, Canada, H3Z 1C3
Actively Recruiting
Research Team
L
Laura Raco
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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