Reducing Wrinkles Around the Eyes Using the Ulthera® System

• Sponsor: Ulthera, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01368900
• Collaborator: (none)
• Enrollment: 68
• Locations: 2
• Arm: 1
• Duration (Months): 10.1
• Patients Per Site: 34
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ulthera System Treatment Ulthera treatment to the upper face.	Device: Ulthera® System treatment; Focused ultrasound energy delivered below the surface of the skin.; Other Names: Ultherapy

Outcome Measures

Primary Outcome Measures

1. Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes [90 days post-treatment]

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

Secondary Outcome Measures

1. Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment [60 days post-treatment]

   At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse "Any Improvement" includes subjects assessed in categories 1-3.

2. Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment [90 days post-treatment]

   At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse "Any Improvement" includes subjects assessed in categories 1-3.

3. Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment [180 days post-treatment]

   At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse "Any Improvement" includes subjects assessed in categories 1-3.

4. Patient Satisfaction Questionnaire 90 Days Post-treatment [90 days post-treatment]

   Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.

5. Patient Satisfaction Questionnaire at 180 Days Post-treatment [180 days post-treatment]

   Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.

Other Outcome Measures

1. Subject Assessment of Pain [Average pain scores reported during study treatment]

   Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Laser Skin & Vein Institute	Hunt Valley	Maryland	United States	21030
2	The Nashville Centre for Laser and Facial Surgery	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Ulthera, Inc

Investigators

• Principal Investigator: Robert Weiss, M.D., MD Laser Skin & Vein Institute
• Principal Investigator: Brian Biesman, M.D., The Nashville Centre for Laser and Facial Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ulthera, Inc
• ClinicalTrials.gov Identifier: NCT01368900
• Other Study ID Numbers: ULT-111
• First Posted: Jun 8, 2011
• Last Update Posted: Dec 13, 2017
• Last Verified: Sep 1, 2013

• Keywords provided by Ulthera, Inc: Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Study Results

Participant Flow

Recruitment Details	Sixty-eight subjects were enrolled at two aesthetic medical facilities. Study recruitment was initiated on March 3, 2011, and concluded on July 13, 2011. Forty-five subjects were enrolled at one study site; 23 subjects were enrolled at the second study site.
Pre-assignment Detail	Subjects presenting with rhytids and skin laxity in the periorbital region, Fitzpatrick Wrinkle Classification Scale (FWCS)of 3 to 7, qualified for study participation. Note: A protocol amendment restricting enrollment to FWCS scores of 3-7 occurred after 19 subjects with FWCS = 2 had been enrolled.

Arm/Group Title	Treated Subjects
Arm/Group Description	The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation. Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds. All study subjects received an Ulthera treatment to the upper face.
Period Title: Overall Study
STARTED	68
COMPLETED	61
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Treated Subjects
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Overall Participants	68
Age (years) [Mean (Full Range) ]
Mean (Full Range)	51
Sex: Female, Male (Count of Participants)
Female	66 97.1%
Male	2 2.9%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	66 97.1%
African American/Black	1 1.5%
Asian	1 1.5%
Region of Enrollment (participants) [Number]
United States	68 100%
Fitzpatrick Skin Type (participants) [Number]
Skin Type I	0 0%
Skin Type II	18 26.5%
Skin Type III	48 70.6%
Skin Type IV	1 1.5%
Skin Type V	1 1.5%
Skin Type VI	0 0%

Outcome Measures

1. Primary Outcome

Title	Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Description	Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
Time Frame	90 days post-treatment

Outcome Measure Data

Analysis Population Description

Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.

Arm/Group Title	Subjects Treated
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Measure Participants	64
Left Eye (1.5mm Transducer)	47 69.1%
Right Eye (1.0mm Transducer)	50 73.5%

2. Secondary Outcome

Title	Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
Description	At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse "Any Improvement" includes subjects assessed in categories 1-3.
Time Frame	60 days post-treatment

Outcome Measure Data

Analysis Population Description

At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

Arm/Group Title	Subjects Treated
Arm/Group Description	All study subject received an Ulthera treatment to the upper face.
Measure Participants	66
PGAIS - Improved to Very Much Improved	60.6 89.1%
SGAIS - Improved to Very Much Improved	66.7 98.1%

3. Secondary Outcome

Title	Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
Description	At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse "Any Improvement" includes subjects assessed in categories 1-3.
Time Frame	90 days post-treatment

Outcome Measure Data

Analysis Population Description

Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.

Arm/Group Title	Subjects Treated
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Measure Participants	67
PGAIS - Improved to Very Much Improved	59.7 87.8%
SGAIS - Improved to Very Much Improved	67.2 98.8%

4. Secondary Outcome

Title	Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
Description	At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse "Any Improvement" includes subjects assessed in categories 1-3.
Time Frame	180 days post-treatment

Outcome Measure Data

Analysis Population Description

Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.

Arm/Group Title	Subjects Treated
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Measure Participants	61
PGAIS - Improved to Very Much Improved	77.0 113.2%
SGAIS - Improved to Very Much Improved	68.9 101.3%

5. Secondary Outcome

Title	Patient Satisfaction Questionnaire 90 Days Post-treatment
Description	Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
Time Frame	90 days post-treatment

Outcome Measure Data

Analysis Population Description

Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.

Arm/Group Title	Subjects Treated
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Measure Participants	67
Number [percentage of participants Satisfied]	77.6 114.1%

6. Secondary Outcome

Title	Patient Satisfaction Questionnaire at 180 Days Post-treatment
Description	Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
Time Frame	180 days post-treatment

Outcome Measure Data

Analysis Population Description

Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.

Arm/Group Title	Treated Subjects
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Measure Participants	60
Number [percentage of participants Satisfied]	72.1 106%

7. Other Pre-specified Outcome

Title	Subject Assessment of Pain
Description	Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.
Time Frame	Average pain scores reported during study treatment

Outcome Measure Data

Analysis Population Description

The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.

Arm/Group Title	Treated Subjects
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
Measure Participants	68
Brow pain score	5.5
Lateral Orbit pain score	4.8
Infraorbit pain score	4.3

Adverse Events

Arm/Group Title	Treated Subjects
Arm/Group Description	All study subjects received an Ulthera treatment to the upper face.
All Cause Mortality
	Treated Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treated Subjects
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Other (Not Including Serious) Adverse Events
	Treated Subjects
	Affected / at Risk (%)	# Events
Total	5/68 (7.4%)
Skin and subcutaneous tissue disorders
Visible Treatment Lines	5/68 (7.4%)	5

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.