PLLA and CaHA-R for Aesthetic Rejuvenation

NCT ID: NCT07202117

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (PLLA - Sculptra® Aesthetic)

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

Group Type: EXPERIMENTAL

Sculptra Aesthetic

Intervention Type: 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 B (CaHA-R - RadiesseTM)

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

Group Type: EXPERIMENTAL

Radiesse

Intervention Type: 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.

Interventions

Sculptra Aesthetic

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.

Intervention Type: DEVICE

Radiesse

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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

3. Immune-competent adult pre-menopausal women 21 years of age and older.

4. Has intent to undergo treatment to improve appearance of the cheeks and décolletage.

5. Could benefit from injectable treatment to improve appearance of the cheeks and the décolletage, in the opinion of the Treating Investigator.

6. 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).

7. Negative UPT for women of childbearing potential at the Baseline visit.

8. 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

1. Known/previous allergy or hypersensitivity to any of the Sculptra constituents.

2. Hypersensitivity to RADIESSE, or CaHA-R-based fillers.

3. Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.

4. Previous or present severe or multiple allergies, such as anaphylaxis or angioedema, or family history of these conditions.

5. Previous surgery in or near the treatment area, including but not limited to liposuction.

6. Previous treatment/procedure in or near the treatment area:

1. Previous permanent implant, lifting threads in the treatment area, regardless of time.

2. Previous semi-permanent implants exemplified by CaHA-R, PLLA in treatment area, within the last 18 months of screening.

3. Previous hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months of screening.

4. Previous energy-based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency, HIFEM and endermologie) in the treatment area within 6 months of screening.

5. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. medical chemical peel) in the treatment area within 6 months of screening.

6. Previous treatment with cryolipolysis, lipolytic treatments, ultrasound treatment, carboxytherapy or liporeduction massage in the treatment area within 6 months of screening.

7. 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.

7. History of cancer or previous radiation near or on the area to be treated.

8. Heavy smokers, classified as smoking more than 12 cigarettes per day.

9. Presence of any active disease or lesions near or on the area to be treated, e.g.

1. Inflammation, active or chronic infection in or near the treatment area

2. Psoriasis, eczema, herpes zoster and acanthosis

3. Cancer or precancerous condition (e.g. actinic keratosis)

4. Severe skin laxity, flaccidity, or sagging

5. 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 Investigator's opinion could interfere with the safety or effectiveness of the study product or injection procedure.

10. 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.

11. 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.

12. Intends to initiate a weight loss program during the study (e.g., restrictive diets, GLP-1 agonists).

13. 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.

14. 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.

15. Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).

16. 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.

17. 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.

18. Pregnancy (confirmed by positive urine pregnancy test (UPT)/ serum pregnancy test), breast feeding or intends to become pregnant over the duration of the study.

19. 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.

• 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.

20. Participation in any interventional clinical study within 30 days of screening.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erevna Innovations Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Nikolis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erevna Innovations Inc.

Locations

Erevna Innovations Inc.

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Laura Raco

Role: CONTACT

lraco@vicpark.com

514-488-0163 ext. 246

Facility Contacts

Andreas Nikolis, MD

Role: primary

research@vicpark.com

514-488-0163 Ext. 246

Other Identifiers

GAL-2025-PLLA-68

Identifier Type: -

Identifier Source: org_study_id