Clinical trial NCT01981252: Peri-orbital and Peri-oral Wrinkle Reduction Trial
Official title: Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peri-orbital Wrinkles
Peri-oral Wrinkles
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Micro-focused Ultrasound with Visualization (MFU-V)
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
timeFrame: 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.
timeFrame: Participants will be followed to 180 days post-treatment #2
measure: Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2.
timeFrame: Participants will be followed to 90 days post-treatment #2
measure: Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2.
timeFrame: Participants will be followed to 180 days post-treatment #2
measure: Overall Aesthetic Improvement
timeFrame: Participants will be followed to 90 days post-treatment #2
measure: Overall Aesthetic Improvement
timeFrame: Participants will be followed to 180 days post-treatment #2
measure: Subject Satisfaction
timeFrame: Participants will be followed to 90 days post-treatment #2
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Center for Advanced Facial Plastic Surgery
state: California
city: Laguna Beach
country: United States
facility: Aesthetic Plastic Surgical Institute
state: California
city: Englewood
country: United States
facility: About Skin Dermatology and DermSurgery, PC
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Research Institute
state: Florida
city: Nashville
country: United States
facility: Nashville Centre for Laser and Facial Surgery
state: Tennessee
Study officials:
affiliation: Nashville Centre for Laser and Facial Surgery
name: Brian Biesman, MD
role: PRINCIPAL_INVESTIGATOR
References: