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

Prospective, Multicenter, Controlled, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of Diluted RADIESSE® for Treatment of Décolleté Wrinkles

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

Study Overview

• Status: Completed
• Conditions: Décolleté Wrinkles
• Intervention / Treatment: Device: Treatment with diluted Radiesse

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
    • Redondo Beach, California, United States, 90277
      • Facial Plastic Surgery, Merz Investigational Site #0010463
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology, Merz Investigational Site #0010321
    • Santa Monica, California, United States, 90404
      • Private Practice, Merz Investigational Site #0010299
    • Vista, California, United States, 92083
      • Face Beautiful Inc, Merz Investigational Site #0010358
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Associates of South Florida, Merz Investigational Site #0010101
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • The Graivier Center, Merz Investigational Site #0010464
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Center for Laser and Facial Surgery, Merz Investigational Site #0010353

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with diluted Radiesse; Injection of Décolleté Wrinkles with diluted Radiesse	Device: Treatment with diluted Radiesse; Injection of Décolleté Wrinkles with diluted Radiesse
Other: Delayed treatment with diluted Radiesse; Delayed injection of Décolleté Wrinkles with diluted Radiesse	Device: Treatment with diluted Radiesse; Injection of Décolleté Wrinkles with diluted Radiesse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders on Merz Aesthetic Scale (MAS) - at rest	Using the validated 5-point photonumeric MAS where: 0 = no wrinkles to 4= very severe wrinkles	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders on Merz Aesthetic Scale (MAS) - dynamic	Using the validated 5-point photonumeric MAS where: 0 = no wrinkles to 4= very severe wrinkles	Week 24
Percentage of Participants with Improvement on Subject Global Aesthetic Improvement Scale (sGAIS)	Using the 5-point GAIS where: +3 (Very much improved), + 2 (Much improved), + 1 (Improved), 0 (No change), - 1 (Worse), - 2 (Much worse),- 3 (Very much worse)	Week 24
Percentage of Participants with Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS)	Using the 5-point GAIS where: + 3 (Very much improved), + 2 (Much improved), + 1 (Improved), 0 (No change), - 1 (Worse), - 2 (Much worse),- 3 (Very much worse)	Week 24
Number of Participants with TEAEs related to treatment		Baseline to week 84

Collaborators and Investigators

• Sponsor: Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: M930521003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes