Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

• Sponsor: Ulthera, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00747422
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Arm: 1
• Duration (Months): 10
• Patients Per Site: 25
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

Condition or Disease	Intervention/Treatment	Phase
Periorbital Wrinkles	Device: Ulthera™ System	N/A

Detailed Description

The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I	Device: Ulthera™ System; ultrasound treatment

Outcome Measures

Primary Outcome Measures

1. reduction of periorbital wrinkles [3 and 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female, aged 40 to 70 years

• Subject in good health

• Desire improvement in periorbital wrinkles

• Subject provides informed consent and agrees to attend follow-up visits

• Subject signs a HIPPA authorization

Exclusion Criteria:

• Pregnant or lactating

• Has an active systemic or local skin disease that may alter wound healing

• Has significant scarring in test areas

• Has significant open facial wounds or lesions

• Has severe or cystic acne on the face

• Has a metal stent or implant in the face area

• Is a current smoker or has a history of smoking in last 10 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology	San Diego	California	United States	92130
2	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611
3	SkinCare Physicians	Chestnut Hill	Massachusetts	United States	02467
4	Zel Skin and Laser Specialists	Edina	Minnesota	United States	55424

Sponsors and Collaborators

• Ulthera, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ulthera, Inc
• ClinicalTrials.gov Identifier: NCT00747422
• Other Study ID Numbers: ULT-102
• First Posted: Sep 5, 2008
• Last Update Posted: Nov 24, 2017
• Last Verified: Oct 1, 2012

Study Results

No Results Posted as of Nov 24, 2017