Décolleté wrinkles
Conditions
Interventions
Group 1: Participants will receive pre-filled 1.5 milliliter (mL) syringe of Radiesse® Injectable Implant diluted with saline in 1:2 ratio in décolleté as initial treatment on Day 1 followed by two op
Sponsors
Merz Aesthetics GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female participant who meets the requirements of the instructions for use (IFU). 2. Female participant, who is at least 18 years of age and seeking treatment for improvement of décolleté wrinkles of moderate to severe grade according to the judgement of the investigator. The Merz Aesthetics Scales for décolleté wrinkles at rest will be provided as reference. 3. Participant provides written informed consent, including access to medical records at baseline and during the evaluation. 4. Participant understands evaluation procedures and is willing to abide by the procedures during the evaluation. 5. Participant is willing to complete participant assessment questionnaires.
Exclusion criteria
Exclusion criteria: 1. Participant, who rated +3 (very satisfied) based on the satisfaction assessment of décolleté appearance. 2. Participant who has previously been included in this evaluation. 3. Participant is an employee or direct relative of an employee of the evaluation site, the clinical research organization, or Merz.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Related Treatment-emergent Adverse Events (TEAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of Improvement (Score of +1, +2, +3) on the Investigator Global Aesthetic Improvement Scale (iGAIS) Decollete Wrinkles at Week 16 After Last Treatment | — |
Countries
Germany
Outcome results
None listed