Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions

Ulthera, Inc5 sites in 1 country90 target enrollmentOctober 2013

ConditionsPeri-orbital Wrinkles Peri-oral Wrinkles

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peri-orbital Wrinkles
Sponsor: Ulthera, Inc
Enrollment: 90
Locations: 5
Primary Endpoint: Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

August 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ulthera, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age 30 to 75 years.
•Subject in good health.
•Fitzpatrick wrinkle score of 3-7 in the peri-orbital and peri-oral areas.
•Moderate skin laxity in the peri-orbital area contributing to rhytids as assessed by the investigator.
•Understands and accepts the obligation not to undergo any other procedures, including neurotoxin and filler treatments, on the face through the follow-up period.
•Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment.
•Willingness and ability to continue with their current daily skin care routine, with the exception of any use of products containing glycolic acid, for the duration of the study.
•Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
•Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
•Absence of physical or psychological conditions unacceptable to the investigator.

Exclusion Criteria

•Presence of an active systemic or local skin disease that may affect wound healing.
•BMI equal to or greater than 25
•Severe solar elastosis.
•Excessive subcutaneous fat in the area(s) to be treated.
•Mild or severe skin laxity on the area(s) to be treated.
•Significant scarring in the area(s) to be treated.
•Open wounds or lesions in the area(s) to be treated.
•Severe or cystic acne on the area(s) to be treated.
•Active implantables (e.g., pacemakers or defibrillators) or metallic implants in the treatment area.
•Inability to understand the protocol or to give informed consent.

Outcomes

Primary Outcomes

Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.

Time Frame: Participants will be followed to 90 days post-treatment #2

Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2.

Secondary Outcomes

Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2.(Participants will be followed to 180 days post-treatment #2)
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2.(Participants will be followed to 90 days post-treatment #2)
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2.(Participants will be followed to 180 days post-treatment #2)
Overall Aesthetic Improvement(Participants will be followed to 180 days post-treatment #2)
Subject Satisfaction(Participants will be followed to 90 days post-treatment #2)