Peri-orbital and Peri-oral Wrinkle Reduction Trial

Not Applicable

Terminated

• Conditions: Peri-oral Wrinkles; Peri-orbital Wrinkles
• Interventions: Device: Ulthera® System Treatment

• Registration Number: NCT01981252
• Lead Sponsor: Ulthera, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulthera® System Treatment	Ulthera® System Treatment	Ulthera® System treatment of the peri-orbital and peri-oral regions.

Primary Outcome Measures

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

Name	Time	Method
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	Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 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	Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 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	Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 180 days post-treatment #2.
Overall Aesthetic Improvement	Participants will be followed to 180 days post-treatment #2	Overall aesthetic improvement at 180 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS).
Subject Satisfaction	Participants will be followed to 90 days post-treatment #2	Subject satisfaction will be measured at using a Patient Satisfaction Questionnaire.

Trial Locations

Locations (5)

Center for Advanced Facial Plastic Surgery; 🇺🇸 Beverly Hills, California, United States

Dermatology Research Institute; 🇺🇸 Coral Gables, Florida, United States

Nashville Centre for Laser and Facial Surgery; 🇺🇸 Nashville, Tennessee, United States

About Skin Dermatology and DermSurgery, PC; 🇺🇸 Englewood, Colorado, United States

Aesthetic Plastic Surgical Institute; 🇺🇸 Laguna Beach, California, United States