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

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

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

Conditions
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Décolleté Wrinkles

Intervention / Treatment
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* Device: Treatment with diluted Radiesse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with diluted Radiesse<br>Injection of Décolleté Wrinkles with diluted Radiesse | Device: Treatment with diluted Radiesse<br>* Injection of Décolleté Wrinkles with diluted Radiesse<br>|
| Other: Delayed treatment with diluted Radiesse<br>Delayed injection of Décolleté Wrinkles with diluted Radiesse | Device: Treatment with diluted Radiesse<br>* Injection of Décolleté Wrinkles with diluted Radiesse<br>|

What is the study measuring?
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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 |