Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles
- Conditions
- Décolleté Wrinkles
- Interventions
- Device: Treatment with diluted Radiesse
- Registration Number
- NCT05163353
- Lead Sponsor
- Merz North America, Inc.
- Brief Summary
Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 152
- Female between ≥ 30 and ≤ 65 years old at the time of the screening.
- Subjects seeking improvement of décolleté wrinkles.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed treatment with diluted Radiesse Treatment with diluted Radiesse Delayed injection of Décolleté Wrinkles with diluted Radiesse Treatment with diluted Radiesse Treatment with diluted Radiesse Injection of Décolleté Wrinkles with diluted Radiesse
- Primary Outcome Measures
Name Time Method Percentage of Responders on Merz Aesthetic Scale (MAS) - at rest Week 24 Using the validated 5-point photonumeric MAS where: 0 = no wrinkles to 4= very severe wrinkles
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) Week 24 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)
Number of Participants with TEAEs related to treatment Baseline to week 84 Percentage of Responders on Merz Aesthetic Scale (MAS) - dynamic Week 24 Using the validated 5-point photonumeric MAS where: 0 = no wrinkles to 4= very severe wrinkles
Percentage of Participants with Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) Week 24 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)
Trial Locations
- Locations (9)
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
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
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
Cosmetic Laser Dermatology, Merz Investigational Site #0010321
🇺🇸San Diego, California, United States
Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
🇺🇸West Palm Beach, Florida, United States