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

Completed · Not applicable

Conditions studied: Décolleté Wrinkles

In brief

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

Key facts

Study ID

NCT05163353

Run by

Merz North America, Inc.

People needed

152

Starts

2021-12-10

Expected to finish

2025-06-11

Last updated by the study team

2025-10-20

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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