AestheticPhase 4NCT07202117
PLLA and CaHA-R for Aesthetic Rejuvenation
A Phase 4 study testing Sculptra Aesthetic and Radiesse in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aesthetic
- What is being tested?
- Sculptra Aesthetic and Radiesse
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2026to 1 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
- Presence of any active disease or lesions near or on the area to be treated, e.g.
- Inflammation, active or chronic infection in or near the treatment area
- Psoriasis, eczema, herpes zoster and acanthosis
- Cancer or precancerous condition (e.g. actinic keratosis)
- Severe skin laxity, flaccidity, or sagging
- 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.
- 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.
- 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.
- Participation in any interventional clinical study within 30 days of screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Erevna Innovations Inc.
Montreal, Quebec, H3Z 1C3
Andreas Nikolis, MD, 514-488-0163 Ext. 246, research@vicpark.com
About this study
Official title: Comparing Outcomes of Collagen Biostimulatory Agents: A Randomized, Patient and Evaluator-blinded Clinical Trial Evaluating Poly-L-lactic Acid and Calcium Hydroxyapatite for Rejuvenation of the Face and Body
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
- Being tested
- Sculptra Aesthetic, Radiesse
- Keywords
- Poly-L-Lactic-Acid, Calcium Hydroxyapatite, Injectable, Biostimulator, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra AestheticDevice
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.
RadiesseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Radiesse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 1) to Week 40 (Visit 6)
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline, Week 20 (Visit 4), Week 30 (Visit 5), Week 40 (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start21 Sep 2026
- Primary completion21 Sep 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Controlled, Parallel-Group Clinical Trial with Unequal Allocation (2:1 ratio)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, PhD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202117
- Sponsor's protocol ID
- GAL-2025-PLLA-68
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes of Collagen Biostimulatory Agents: A Randomized, Patient and Evaluator-blinded Clinical Trial Evaluating Poly-L-lactic Acid and Calcium Hydroxyapatite for Rejuvenation of the Face and Body
- ClinicalTrials.gov ID
- NCT07202117
- Acronym / sponsor ID
- GAL-2025-PLLA-68
- Conditions
- Aesthetic
- Keywords
- Poly-L-Lactic-Acid, Calcium Hydroxyapatite, Injectable, Biostimulator, Aging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 21 Sep 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Controlled, Parallel-Group Clinical Trial with Unequal Allocation (2:1 ratio)
| Arm | Type | Receives |
|---|---|---|
| Group A (PLLA - Sculptra® Aesthetic) | Experimental | Device: Sculptra AestheticThirty (30) participants will receive up to three treatment of PLLA - Sculptra® Aesthetic in their face and décolleté region |
| Group B (CaHA-R - RadiesseTM) | Experimental | Device: RadiesseFifteen (15) participants will receive up to three treatment of CaHA-R, Radiesse in their face and décolleté region |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sculptra AestheticSculptra® 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. | Device | Group A (PLLA - Sculptra® Aesthetic) |
| RadiesseRadiesse® 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. | Device | Group B (CaHA-R - RadiesseTM) |
Primary outcome
Change in Skin Elasticity Measured by Cutometer
Time frame: Baseline (Visit 1) to Week 40 (Visit 6)
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.
2 secondary outcomes
Participant Satisfaction with Treatment
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
Time frame: Baseline, Week 20 (Visit 4), Week 30 (Visit 5), Week 40 (Visit 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Nikolis, MD, PhD principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sculptra Aesthetic and Radiesse in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Raco (514-488-0163 ext. 246, lraco@vicpark.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Elasticity Measured by Cutometer (time frame: Baseline (Visit 1) to Week 40 (Visit 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.