Overview

This trial is active, not recruiting.

Conditions peri-orbital wrinkles, peri-oral wrinkles
Treatment ulthera® system treatment
Sponsor Ulthera, Inc
Start date October 2013
End date June 2014
Trial size 90 participants
Trial identifier NCT01981252, ULT-137

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ulthera® System treatment of the peri-orbital and peri-oral regions.
ulthera® system treatment Ultherapy®
Focused ultrasound energy delivered below the surface of the skin

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2.
time frame: 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.
time frame: 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.
time frame: Participants will be followed to 180 days post-treatment #2
Overall Aesthetic Improvement
time frame: Participants will be followed to 90 days post-treatment #2
Overall Aesthetic Improvement
time frame: Participants will be followed to 180 days post-treatment #2
Subject Satisfaction
time frame: Participants will be followed to 90 days post-treatment #2

Eligibility Criteria

Male or female participants from 30 years up to 75 years old.

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. - 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. 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. - 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: 1. Skin tightening procedure within the past year; 2. Injectable fillers of any type within the past 12 or 24 months, depending on type; 3. Neurotoxins within the past six months; 4. Ablative resurfacing laser treatment; 5. Nonablative, rejuvenative laser or light treatment within the past six months; 6. Surgical dermabrasion or deep facial peels; 7. Facelift, blepharoplasty, or browlift within the past 2 years; or 8. Any history of contour threads. - History of using the following prescription medications: 1. Accutane or other systemic retinoids within the past six months; 2. Topical Retinoids within the past four weeks; 3. Antiplatelet agents/Anticoagulants; 4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Additional Information

Official title Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions
Principal investigator Brian Biesman, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Ulthera, Inc.