Clinical trial NCT01368900: Reducing Wrinkles Around the Eyes Using the Ulthera® System
Official title: Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Wrinkles
Keywords: Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
timeFrame: 60 days post-treatment
measure: Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
timeFrame: 90 days post-treatment
measure: Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
timeFrame: 180 days post-treatment
measure: Patient Satisfaction Questionnaire 90 Days Post-treatment
timeFrame: 90 days post-treatment
measure: Patient Satisfaction Questionnaire at 180 Days Post-treatment
timeFrame: 180 days post-treatment
Other outcomes:
measure: Subject Assessment of Pain
timeFrame: Average pain scores reported during study treatment
Locations:
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein Institute
state: Maryland
city: Nashville
country: United States
facility: The Nashville Centre for Laser and Facial Surgery
state: Tennessee
Study officials:
affiliation: MD Laser Skin & Vein Institute
name: Robert Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nashville Centre for Laser and Facial Surgery
name: Brian Biesman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: