Sculptra Aesthetic + Radiesse for Cosmetic Rejuvenation

Overseen By Laura Raco

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Erevna Innovations Inc.

Must not be taking: Anticoagulants, Immunosuppressants, Corticosteroids, Retinoids

Disqualifiers: Cancer, Heavy smoking, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 40 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Sculptra Aesthetic and Radiesse, to evaluate their effectiveness in rejuvenating skin affected by aging. Both treatments aim to boost collagen production, improving skin firmness and reducing wrinkles. Participants will receive either Sculptra Aesthetic (PLLA, a poly-L-lactic acid treatment) or Radiesse (CaHA-R, a calcium hydroxylapatite treatment) in the face and décolleté (upper chest) region. Women with noticeable skin irregularities on their cheeks and upper chest who wish to improve their appearance may be suitable candidates for this trial. As a Phase 4 trial, these treatments are already FDA-approved and have proven effective, helping to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial requires you to stop taking medications that can prolong bleeding times, like blood thinners and certain supplements, at least 14 days before the injection. If you're on hormonal replacement therapy, you must have been on a stable dose for at least 3 months before the trial and not plan to change it during the study. Other medications like systemic corticosteroids and certain topical treatments must also be stopped before the trial.

What is the safety track record for these treatments?

Research has shown that both PLLA (Sculptra® Aesthetic) and CaHA-R (Radiesse™) are generally safe and well-tolerated for cosmetic rejuvenation.

PLLA boosts collagen production, improving skin appearance for two to three years. Common side effects include redness, swelling, or bruising at the injection site, but these are usually mild and resolve on their own. Individuals allergic to any ingredient in PLLA or prone to keloid scars should avoid it.

CaHA-R provides immediate volume improvement lasting about 12-18 months. It is also well-tolerated, with side effects like minor swelling or bruising that typically resolve quickly. Radiesse is not recommended for individuals with severe allergies or a history of severe allergic reactions.

Both treatments have been used in cosmetic procedures for some time, supporting their safety. Always consult a healthcare provider before joining a clinical trial to ensure these treatments are suitable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer innovative approaches to cosmetic rejuvenation. Unlike other treatments that typically focus on surface-level enhancements, Sculptra® Aesthetic (PLLA) works by stimulating the body's own collagen production, promoting gradual and natural-looking improvements in skin texture and volume. RadiesseTM (CaHA-R), on the other hand, provides immediate volume while also encouraging collagen production over time, combining instant results with long-term benefits. These treatments stand out for their dual-action capabilities, offering both immediate and sustained improvements, which could potentially lead to more natural and enduring aesthetic results compared to traditional fillers.

What evidence suggests that this trial's treatments could be effective for cosmetic rejuvenation?

Research has shown that Sculptra Aesthetic (PLLA), administered to participants in Group A of this trial, can increase skin thickness by over 50% after a year, reducing wrinkles and firming the skin. Many patients report satisfaction with this treatment, with 92% expressing contentment. Meanwhile, Radiesse (CaHA-R), given to participants in Group B, boosts collagen and elastin, essential for healthy, youthful skin. This treatment is known for long-lasting improvements, particularly in areas like the jawline and the lines from the nose to the mouth. Both treatments have demonstrated promising results in enhancing the skin's appearance and texture. ^{2 5 6 7 8}

Who Is on the Research Team?

Andreas Nikolis, MD, PhD

Principal Investigator

Erevna Innovations Inc.

Are You a Good Fit for This Trial?

This trial is for individuals seeking cosmetic improvement in skin aging signs like wrinkles and loss of firmness. Participants should be healthy adults willing to undergo injections with collagen stimulators. Specific eligibility criteria are not provided, so it's assumed that a detailed assessment will determine suitability.

Inclusion Criteria

Ability to understand and provide consent in local language

Negative UPT for women of childbearing potential at Baseline visit

Agrees to use same topical cosmetic products throughout trial period

Exclusion Criteria

Initiation of weight loss program during study

Known/previous allergy or hypersensitivity to Sculptra constituents

Hypersensitivity to RADIESSE or CaHA-R-based fillers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to three treatments of either PLLA or CaHA-R in their face and décolleté region

40 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CaHA-R
• PLLA

Trial Overview The study tests two collagen stimulators: Sculptra Aesthetic (PLLA) and Radiesse (CaHA-R), injected into the skin to improve elasticity and firmness. It aims to compare their effectiveness over time, with PLLA results lasting up to three years and CaHA-R around 12-18 months.

How Is the Trial Designed?

Group I: Group B (CaHA-R - RadiesseTM) Experimental Treatment 1 Intervention

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

Group II: Group A (PLLA - Sculptra® Aesthetic) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Erevna Innovations Inc.

Lead Sponsor

Trials

13

Recruited

340+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12193805/

Calcium Hydroxylapatite-Based Fillers in Facial Rejuvenation Rennova Diamond Intense effectively increases dermal thickness, improves skin elasticity, and reduces transepidermal water loss, achieving high patient and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07202117

PLLA and CaHA-R for Aesthetic Rejuvenation 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.

3. academic.oup.com academic.oup.com/asj/article/43/10/1063/7249933

The Role of Calcium Hydroxylapatite (Radiesse) as a ... Radiesse treatment results in increases of collagen, elastin, vasculature, proteoglycans, and fibroblast populations via a cell-biomaterial–mediated ...

4. mdpi.com mdpi.com/2077-0383/13/6/1686

Calcium Hydroxylapatite (CaHA) and Aesthetic Outcomes Current evidence suggests that CaHA injections improve aesthetic results, including facial areas, such as nasolabial folds and jawline, and hands, with high ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38934231/

Long-term duration and safety of Radiesse (+) for the ... CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf5/P050052S129B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) RADIESSE® (+) is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf5/p050037c.pdf

RADIESSE® Radiesse results in aesthetic improvement and provides an increase in cheek thickness in the treated area. Visible results appear at the first treatment session ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16436

Long‐term duration and safety of Radiesse (+) for the ... CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks.