Peri-orbital and Peri-oral Wrinkle Reduction Trial

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

NCT01981252•Ulthera, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female, age 30 to 75 years.
•Subject in good health.
•BMI\<25
•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.
+3 more criteria

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.
+26 more criteria

Locations (5)

Center for Advanced Facial Plastic Surgery

Beverly Hills, California, United States

Aesthetic Plastic Surgical Institute

Laguna Beach, California, United States

About Skin Dermatology and DermSurgery, PC

Englewood, Colorado, United States

Dermatology Research Institute

Coral Gables, Florida, United States

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

November 24, 2017

Enrollment

ACTUAL participants

Conditions

Peri-orbital WrinklesPeri-oral Wrinkles

Interventions

Ulthera® System Treatment

DEVICE