Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles

NCT05163353 | Completed Results FDA Device

• 1 other identifier: M930521003
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 9

Brief Summary

Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.

Conditions

Décolleté Wrinkles

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24

  The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.

  Week 24

Secondary Outcomes (4)

• Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24

  Week 24

• Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24

  Week 24

• Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24

  Week 24

• Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse

  From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84)

Study Arms (2)

Treatment with diluted Radiesse

EXPERIMENTAL

Injection of Décolleté Wrinkles with diluted Radiesse

Device: Treatment with diluted Radiesse

Delayed treatment with diluted Radiesse

OTHER

Delayed injection of Décolleté Wrinkles with diluted Radiesse

Device: Treatment with diluted Radiesse

Interventions

Treatment with diluted Radiesse DEVICE

Injection of Décolleté Wrinkles with diluted Radiesse

Delayed treatment with diluted Radiesse; Treatment with diluted Radiesse

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female between ≥ 30 and ≤ 65 years old at the time of the screening.
• Subjects seeking improvement of décolleté wrinkles.

You may not qualify if:

• Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.
• Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté.
• Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (9)

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395

Beverly Hills, California, 90210, United States

Location

Facial Plastic Surgery, Merz Investigational Site #0010463

Redondo Beach, California, 90277, United States

Location

Cosmetic Laser Dermatology, Merz Investigational Site #0010321

San Diego, California, 92121, United States

Location

Private Practice, Merz Investigational Site #0010299

Santa Monica, California, 90404, United States

Location

Face Beautiful Inc, Merz Investigational Site #0010358

Vista, California, 92083, United States

Location

Skin Associates of South Florida, Merz Investigational Site #0010101

Coral Gables, Florida, 33146, United States

Location

Research Institute of the Southeast, LLC, Merz Investigational Site #0010420

West Palm Beach, Florida, 33401, United States

Location

The Graivier Center, Merz Investigational Site #0010464

Alpharetta, Georgia, 30005, United States

Location

Nashville Center for Laser and Facial Surgery, Merz Investigational Site #0010353

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

Therapeutics

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Aesthetics

Aesthetic.Trials@merz.com

+1 984-301-3095

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: December 10, 2021
• Primary Completion: September 29, 2022
• Study Completion: June 11, 2025
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)