Periorbital Wrinkles
Conditions
Keywords
Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
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.
Interventions
Focused ultrasound energy delivered below the surface of the skin.
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3. |
| 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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3. |
| 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. |
| 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. |
| 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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treated Subjects All study subjects received an Ulthera treatment to the upper face. | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Treated Subjects |
|---|---|
| Age, Continuous Mean (Full Range) | 51 years |
| Fitzpatrick Skin Type Skin Type I | 0 participants |
| Fitzpatrick Skin Type Skin Type II | 18 participants |
| Fitzpatrick Skin Type Skin Type III | 48 participants |
| Fitzpatrick Skin Type Skin Type IV | 1 participants |
| Fitzpatrick Skin Type Skin Type V | 1 participants |
| Fitzpatrick Skin Type Skin Type VI | 0 participants |
| Race/Ethnicity, Customized African American/Black | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 66 participants |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
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.
Time frame: 90 days post-treatment
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Treated | Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes | Left Eye (1.5mm Transducer) | 47 percentage of participants improved |
| Subjects Treated | Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes | Right Eye (1.0mm Transducer) | 50 percentage of participants improved |
Secondary
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3.
Time frame: 180 days post-treatment
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Treated | Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment | PGAIS - Improved to Very Much Improved | 77.0 percentage of participants improved |
| Subjects Treated | Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment | SGAIS - Improved to Very Much Improved | 68.9 percentage of participants improved |
Secondary
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3.
Time frame: 60 days post-treatment
Population: At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Treated | Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment | PGAIS - Improved to Very Much Improved | 60.6 percentage of participants improved |
| Subjects Treated | Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment | SGAIS - Improved to Very Much Improved | 66.7 percentage of participants improved |
Secondary
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3.
Time frame: 90 days post-treatment
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Treated | Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment | PGAIS - Improved to Very Much Improved | 59.7 percentage of participants improved |
| Subjects Treated | Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment | SGAIS - Improved to Very Much Improved | 67.2 percentage of participants improved |
Secondary
Patient Satisfaction Questionnaire 90 Days Post-treatment
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
Time frame: 90 days post-treatment
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated | Patient Satisfaction Questionnaire 90 Days Post-treatment | 77.6 percentage of participants Satisfied |
Secondary
Patient Satisfaction Questionnaire at 180 Days Post-treatment
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
Time frame: 180 days post-treatment
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated | Patient Satisfaction Questionnaire at 180 Days Post-treatment | 72.1 percentage of participants Satisfied |
Other Pre-specified
Subject Assessment of Pain
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subjects Treated | Subject Assessment of Pain | Brow pain score | 5.5 units on a scale |
| Subjects Treated | Subject Assessment of Pain | Lateral Orbit pain score | 4.8 units on a scale |
| Subjects Treated | Subject Assessment of Pain | Infraorbit pain score | 4.3 units on a scale |