Reducing Wrinkles Around the Eyes Using the Ulthera® System

NCT01368900 | Completed Results

• 1 other identifier: ULT-111
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

Conditions

Periorbital Wrinkles

Keywords

Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Outcome Measures

Primary Outcomes (1)

• Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes

  Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.

  90 days post-treatment

Secondary Outcomes (5)

• Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment

  60 days post-treatment

• Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment

  90 days post-treatment

• Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment

  180 days post-treatment

• Patient Satisfaction Questionnaire 90 Days Post-treatment

  90 days post-treatment

• Patient Satisfaction Questionnaire at 180 Days Post-treatment

  180 days post-treatment

Other Outcomes (1)

• Subject Assessment of Pain

  Average pain scores reported during study treatment

Study Arms (1)

Ulthera System Treatment

EXPERIMENTAL

Ulthera treatment to the upper face.

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

You may qualify if:

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Mild to moderate rhytids in the periorbital region.
• Willingness and ability to comply with protocol requirements and return for follow-up visits.
• Not pregnant.
• Provide written informed consent and HIPAA authorization.

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face.
• Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
• Excessive hooding, with or without redundant skin, in the areas to be treated.
• Significant scarring in areas to be treated.
• Significant open facial wounds or lesions.
• Severe or cystic acne on the face.
• Presence of a metal stent or implant in the facial area to be treated.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (2)

MD Laser Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

The Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Limitations and Caveats

FWCS scores assessed globally, not per eye, leading to limited data for analysis. FWCS protocol amended to 3+ after enrollment of 19 subjects with FWCS of 2. Unacceptable lighting, focus, exposure making some photos impossible to evaluate.

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Robert Weiss, M.D.

  MD Laser Skin & Vein Institute

  PRINCIPAL INVESTIGATOR

• Brian Biesman, M.D.

  The Nashville Centre for Laser and Facial Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 6, 2011
• First Posted: June 8, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 13, 2017
• Results First Posted: July 31, 2013

Record last verified: 2013-09

Locations

US (2)