About the Study
This study is evaluating SIMULINES® transducers used with the Ulthera® System to determine whether this investigational approach may safely and effectively improve the appearance of lines and wrinkles in the décolleté area.
Now enrolling · Women ages 35 – 65
A Clinical Research Study for Lines and Wrinkles of the Décolleté
Women ages 35 – 65 with moderate to severe lines, wrinkles, laxity, or crepey skin of the décolleté may be eligible. We invite you to learn more about a clinical study evaluating an investigational treatment for lines and wrinkles of the décolleté.
Study Overview
Understanding this research study
What Could Participation Look Like?
If you qualify and choose to participate, you will receive one study treatment to the décolleté area and return for follow-up assessments over approximately 6 months. The study is designed to help researchers evaluate whether the investigational treatment may improve the appearance of lines and wrinkles over time.
What Can I Expect During the Treatment?
The study treatment is performed at a study site. After treatment, you will be monitored for at least 30 minutes. You will need someone to drive you home after the treatment visit. Some discomfort during the treatment is possible, and the study team will monitor your comfort throughout the treatment.
Eligibility
You may qualify if…
Final eligibility will be determined by the study team based on study requirements.
- Women ages 35 – 65
- Generally healthy
- Moderate to severe décolleté lines, wrinkles, laxity, or crepiness
- Do not have breast implants or plan to receive breast implants during the study
- Additional study requirements apply
What to Expect
Participation, step by step
- 1
Complete an Online Eligibility Questionnaire
Answer a few questions to see whether you may meet the initial study criteria and find the location of your closest participating study site.
- 2
Speak With a Study Coordinator
If potentially eligible based on your screening questions, a study coordinator will reach out to discuss the study and answer any questions.
- 3
Screening
The team at your closest participating study site will determine final eligibility during a screening visit.
- 4
One Study Treatment
If eligible, you will receive a single study treatment to the décolleté area.
- 5
Follow-Up
After treatment, you will have approximately 4 follow-up visits over the next 6 months, as well as a brief telephone follow-up, to complete study assessments.
FAQs
Frequently asked questions
This study is evaluating the safety and effectiveness of investigational SIMULINES® transducers used with the Ultherapy® system. The system uses focused ultrasound energy. The study is evaluating the investigational transducers for improving the appearance of lines and wrinkles of the décolleté (upper chest area).
Interested in taking the next step?
Complete a short online questionnaire to see whether you may be eligible for this clinical research study.