PLLA and CaHA-R for Aesthetic Rejuvenation

NCT07202117 | Recruiting Phase 4

• 1 other identifier: GAL-2025-PLLA-68
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Aesthetic

Keywords

Poly-L-Lactic-Acid; Calcium Hydroxyapatite; Injectable; Biostimulator; Aging

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline (Visit 1) to Week 40 (Visit 6)

Secondary Outcomes (2)

• Participant Satisfaction with Treatment

  Week 20 (Visit 4), Week 30 (Visit 5), and Week 40 (Visit 6)

• Global Aesthetic Improvement Scale (GAIS) as Assessed by a Blinded Evaluator

  Baseline, Week 20 (Visit 4), Week 30 (Visit 5), Week 40 (Visit 6)

Other Outcomes (11)

• Change in Facial Laxity Rating (FLR) and Galderma Decolletage Scale (GDS) as assessed by a blinded evaluator

  Baseline, Week 20 (Visit 4), Week 30 (Visit 5), and Week 40 (Visit 6)

• Volume of Product Used

  Baseline to Week 40 (Visit 6)

• Change in Skin Hydration Using the Corneometer CM 825 probe

  Baseline, Week 20 (Visit 4), Week 30 (Visit 5), and Week 40 (Visit 6)

Study Arms (2)

Group A (PLLA - Sculptra® Aesthetic)

EXPERIMENTAL

Thirty (30) participants will receive up to three treatment of PLLA - Sculptra® Aesthetic in their face and décolleté region

Device: Sculptra Aesthetic

Group B (CaHA-R - RadiesseTM)

EXPERIMENTAL

Fifteen (15) participants will receive up to three treatment of CaHA-R, Radiesse in their face and décolleté region

Device: Radiesse

Interventions

Sculptra Aesthetic DEVICE

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.

Group A (PLLA - Sculptra® Aesthetic)

Radiesse DEVICE

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.

Group B (CaHA-R - RadiesseTM)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3Z 1C3, Canada

RECRUITING

Study Officials

• Andreas Nikolis, MD, PhD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Raco

CONTACT

514-488-0163; lraco@vicpark.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Controlled, Parallel-Group Clinical Trial with Unequal Allocation (2:1 ratio)

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)