Simulines Non-Inferiority Pivotal Study
Public ClinicalTrials.gov record NCT02736825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Non-Inferiority Study of the Safety and Efficacy of Ultherapy® Using Standard Versus Simulines Transducers at a Reduced Energy Level for Patient Comfort
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.
Study identification
- NCT ID
- NCT02736825
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 262 participants
Conditions and interventions
Conditions
Interventions
- Ulthera System with standard transducer Device
- Ulthera System with prototype 2 simulines transducer Device
Device
Eligibility (public fields only)
- Age range
- 30 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 11, 2016 (Actual)
- Primary completion
- Jan 20, 2017 (Actual)
- Completion
- Apr 25, 2017 (Actual)
- Last update posted
- Feb 19, 2020
2016 – 2017
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Testing of Beverly Hills | Beverly Hills | California | 90210 | — |
| Roseville Facial Plastic Surgery | Roseville | California | 95661 | — |
| Laser and Skin Surgery Center | Sacramento | California | 95816 | — |
| Dermatology Cosmetic Laser Medical Associates of La Jolla | San Diego | California | 92121 | — |
| AboutSkin Dermatology | Greenwood Village | Colorado | 80111 | — |
| Maryland Laser Skin and Vein Dermatology | Cockeysville | Maryland | 21030 | — |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28403 | — |
| Premier Clinical Research | Spokane | Washington | 92202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02736825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2020 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02736825 live on ClinicalTrials.gov.