Peri-orbital and Peri-oral Wrinkle Reduction Trial

NCT01981252 | Terminated DMC

• 1 other identifier: ULT-137
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

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.

Conditions

Peri-orbital Wrinkles; Peri-oral Wrinkles

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Micro-focused Ultrasound with Visualization (MFU-V)

Outcome Measures

Primary Outcomes (1)

• Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.

  Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2.

  Participants will be followed to 90 days post-treatment #2

Secondary Outcomes (6)

• 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

• 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

• 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

• Overall Aesthetic Improvement

  Participants will be followed to 90 days post-treatment #2

• Overall Aesthetic Improvement

  Participants will be followed to 180 days post-treatment #2

Study Arms (1)

Ulthera® System Treatment

EXPERIMENTAL

Ulthera® System treatment of the peri-orbital and peri-oral regions.

Device: Ulthera® System Treatment

Interventions

Ulthera® System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy®

Ulthera® System Treatment

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (5)

Center for Advanced Facial Plastic Surgery

Beverly Hills, California, 90212, United States

Location

Aesthetic Plastic Surgical Institute

Laguna Beach, California, 92651, United States

Location

About Skin Dermatology and DermSurgery, PC

Englewood, Colorado, 80113, United States

Location

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Location

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Study Officials

• Brian Biesman, MD

  Nashville Centre for Laser and Facial Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 24, 2017

Record last verified: 2014-10

Locations

US (5)