Diluted Radiesse for Décolleté Wrinkles

Recruiting at 9 trial locations

Overseen By Public Disclosure Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Merz North America, Inc.

Disqualifiers: Previous surgery, Collagen fillers, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

152 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to confirm the effectiveness and safety of using diluted Radiesse to treat wrinkles in the upper chest area by injecting a gel that smooths out wrinkles and boosts natural collagen production. Radiesse is an injectable filler composed of synthetic calcium hydroxylapatite microspheres, known for its collagen-stimulating properties and used for various cosmetic treatments including wrinkle reduction and skin tightening.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Diluted Radiesse for décolleté wrinkles?

Research shows that Diluted Radiesse, a treatment made from a natural component of the body, improves skin quality, elasticity, and firmness. In a study, it was effective in reducing wrinkles and improving skin appearance in 70-95% of people, depending on age, with no significant side effects. ^{1 2 3 4 5}

Is Diluted Radiesse safe for treating décolleté wrinkles?

Diluted Radiesse, which is a form of calcium hydroxylapatite, has been used safely in various treatments for skin rejuvenation, including the face, neck, and décolleté, with no significant adverse effects reported in studies. ^{1 2 4 6 7}

How does the treatment Diluted Radiesse differ from other treatments for décolleté wrinkles?

Diluted Radiesse is unique because it not only fills wrinkles but also stimulates the production of collagen and elastin, which improves skin quality, elasticity, and firmness over time. Unlike other fillers, it is used in a diluted form to enhance skin rejuvenation without adding volume, making it a versatile option for treating décolleté wrinkles. ^{1 2 7 8 9}

Eligibility Criteria

This trial is for women aged 30 to 65 seeking to improve neck wrinkles. Candidates must not have had surgery, permanent implants, or treatments like collagen fillers, calcium hydroxylapatite, long-lasting HA fillers in the décolleté area, or botulinum toxin and certain skin procedures there.

Inclusion Criteria

You want to reduce wrinkles on your chest area.

Female between ≥ 30 and ≤ 65 years old at the time of the screening.

Exclusion Criteria

Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.

You have received certain types of treatments, such as collagen fillers, calcium hydroxylapatite, or long-lasting hyaluronic acid fillers, in your chest area in the past.

You have had certain skin treatments on your chest area before, such as botulinum toxin injections, laser treatments, or chemical peels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Injection of Décolleté Wrinkles with diluted Radiesse

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Diluted Radiesse

Trial Overview The trial tests diluted Radiesse's effectiveness and safety in treating décolleté (neck) wrinkles. Participants will receive this treatment to see how well it corrects these specific types of wrinkles.

Participant Groups

Group I: Treatment with diluted Radiesse Experimental Treatment 1 Intervention

Injection of Décolleté Wrinkles with diluted Radiesse

Group II: Delayed treatment with diluted Radiesse Experimental Treatment 1 Intervention

Delayed injection of Décolleté Wrinkles with diluted Radiesse

Who Is Running the Clinical Trial?

Merz North America, Inc.

Lead Sponsor

Trials

67

Recruited

10,000+

Leonard Paolillo

Merz North America, Inc.

Chief Executive Officer

Bachelor of Science in Business Administration from Manhattan College

Dr. McKinnon

Merz North America, Inc.

Chief Medical Officer since 2024

Ph.D. in Pharmacology and Toxicology from the University of Western Ontario

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Starting Point for Protocols on the Use of Hyperdiluted Calcium Hydroxylapatite (Radiesse®) for Optimizing Age-Related Biostimulation and Rejuvenation of Face, Neck, Décolletage and Hands: A Case Series Report. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Use of calcium hydroxylapatite (Radiesse) for facial augmentation. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Radiesse(®): a novel rejuvenation treatment for the upper arms. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Injectable calcium hydroxylapatite microspheres (Radiesse). [2013]

5. England pubmed.ncbi.nlm.nih.gov

Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Radiesse: Advanced Techniques and Applications for a Unique and Versatile Implant. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Large-particle calcium hydroxylapatite injection for correction of facial wrinkles and depressions. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Diluted Calcium Hydroxylapatite for Skin Tightening of the Upper Arms and Abdomen. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Composite Facial Volumization With Calcium Hydroxylapatite (CaHA) for the Treatment of Aging. [2019]