Peri-orbital and Peri-oral Wrinkle Reduction Trial

Stopped early · Not applicable

Conditions studied: Peri-orbital Wrinkles, Peri-oral Wrinkles

In brief

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.

Key facts

Study ID

NCT01981252

Run by

Ulthera, Inc

People needed

90

Starts

2013-10-01

Expected to finish

2014-08-01

Last updated by the study team

2017-11-24

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if…

• 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.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study.
• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• History of chronic drug or alcohol abuse.
• History of autoimmune disease.
• History of Bell's Palsy or epilepsy.
• History of diabetes.
• Has a known allergy, or a known history of sensitivity, to lidocaine, tetracaine, para-aminobenzoic acid (PABA).
• Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Subjects who anticipate the need for surgery or overnight hospitalization during the study.
• Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
• Concurrent enrollment in any study involving the use of investigational devices or drugs.
• Current smoker or history of smoking in the last five years.
• History of the following cosmetic treatments in the area(s) to be treated:
• Skin tightening procedure within the past year;
• Injectable fillers of any type within the past 12 or 24 months, depending on type;

Where it is running

• 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

Full record on ClinicalTrials.gov

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