N/A
Completed N=25
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
Facial Skin Laxity
Source: ClinicalTrials.gov NCT03545412 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 — 8 Participants
Summary
To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 |
8 | — |
| PRIMARY Number of Participants With Lift in Brow Region at Day 90 |
12 | — |
| SECONDARY Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90 |
21 | — |
| SECONDARY Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 |
21 | — |
| SECONDARY Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90 |
21 | — |
| SECONDARY Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180 |
22 | — |
| SECONDARY Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180 |
20 | — |
Eligibility Criteria
Inclusion Criteria
- Willing to sign a written consent form
- Willing to have of facial skin laxity and wrinkles assessed by clinician
- Male or female, aged 39 to 65 years.
- Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Exclusion Criteria
- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic acne on the area(s) to be treated.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
- Subcutaneous fillers
- Keloid scar
- Patients with anticoagulant treatment plan.
- Children, pregnant women, breastfeeding women.
- Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)
Data sourced from ClinicalTrials.gov (NCT03545412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.