Diluted Radiesse for Décolleté Wrinkles

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called diluted Radiesse (a dermal filler) to determine its effectiveness in reducing wrinkles on the décolleté, the area just below the neck. The main goal is to confirm the treatment's efficacy and safety. Participants are divided into two groups: one receives the treatment immediately, while the other receives it later. Women aged 30 to 65 who wish to improve wrinkles in this area and have not undergone certain cosmetic procedures may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore new cosmetic solutions for wrinkle reduction.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that diluted Radiesse is generally safe for treating wrinkles in the chest area. Studies indicate that most people tolerate it well, with few experiencing serious side effects. It has proven both safe and effective for thickening the skin and reducing wrinkles. Mild side effects, such as redness or swelling, might occur but typically resolve on their own. For those considering participation in a clinical trial, this information suggests that diluted Radiesse is a promising and safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for décolleté wrinkles, which often involve topical creams or surgical procedures, diluted Radiesse offers a unique approach by using an injectable filler that stimulates collagen production. This treatment stands out because it combines calcium hydroxylapatite microspheres with a gel carrier, providing immediate volume while encouraging the body to produce its own collagen over time. Researchers are excited about diluted Radiesse because it not only addresses the wrinkles but also improves skin texture and elasticity, potentially offering longer-lasting and more natural-looking results compared to conventional options.

What evidence suggests that diluted Radiesse is effective for Décolleté Wrinkles?

Research shows that diluted Radiesse can help reduce wrinkles on the chest. One study improved skin thickness, firmness, and wrinkles in up to 95% of people aged 30–40. For those aged 40–60, the improvement rate reached 80%, and for those over 60, it was 70%. Another study confirmed that diluted Radiesse is safe and effective for treating chest wrinkles in women, with over 73% of participants satisfied with the results. These findings suggest that diluted Radiesse, which participants in this trial will receive either immediately or after a delay, could be a promising option for reducing chest wrinkles. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693750/

Starting Point for Protocols on the Use of Hyperdiluted ... The treatment was effective in improving skin thickness, laxity, and wrinkles in 95% of 30–40 year-olds, 80% of 40–60 year-olds, and 70% of >60 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05163353

NCT05163353 | Evaluation of the Effectiveness and Safety ... Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles. Official Title.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38954627/

A Prospective, Multicenter, Evaluator-Blinded, Randomized ... Conclusions: Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.J Drugs Dermatol. 2024;23(7): ...

4. jddonline.com jddonline.com/articles/prospective-multicenter-evaluator-blinded-randomized-study-of-diluted-calcium-hydroxylapatite-treat-decollete-wrinkles-S1545961624P8261X/

A Prospective, Multicenter, Evaluator-Blinded, Randomized ... Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.

5. merzaesthetics.com merzaesthetics.com/news/merz-aesthetics-receives-eu-approval-for-the-new-indication-for-radiesse-as-an-aesthetic-injectable-to-improve-moderate-and-severe-wrinkles-in-the-decollete-area/

Merz Aesthetics receives EU approval for the new ... Radiesse proved a clinically and statistically significant improvement in décolleté wrinkles and overall satisfaction, with 73.5% of the treated ...

6. clinicaltrial.be clinicaltrial.be/en/details/1002?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Evaluation of the Effectiveness and Safety of Diluted RAD... Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles. Trial ...

7. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-effectiveness-and-safety-of-diluted-radiesse-r-in-the-treatment-of-decollete-wrinkl

Evaluation of the Effectiveness and Safety of Diluted ... Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles. Enrollment. 152 patients.