Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera System Treatment | Experimental | Ulthera treatment to the upper face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera® System treatment | Device | Focused ultrasound energy delivered below the surface of the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
"Any Improvement" includes subjects assessed in categories 1-3. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Average pain scores reported during study treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Laser Skin & Vein Institute | Hunt Valley | Maryland | 21030 | United States | ||
| The Nashville Centre for Laser and Facial Surgery |
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treated Subjects | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adults between 30 and 65 years of age who provided informed consent and who met the inclusion/exclusion criteria and required infraorbital, lateral orbit, and brow regions to be treated bilaterally.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treated Subjects | All study subjects received an Ulthera treatment to the upper face. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants improved | 90 days post-treatment |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated Subjects | All study subjects received an Ulthera treatment to the upper face. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visible Treatment Lines | Skin and subcutaneous tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| 60 days post-treatment |
| 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:
"Any Improvement" includes subjects assessed in categories 1-3. | 90 days post-treatment |
| 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:
"Any Improvement" includes subjects assessed in categories 1-3. | 180 days post-treatment |
| Patient Satisfaction Questionnaire 90 Days Post-treatment | Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment. | 90 days post-treatment |
| Patient Satisfaction Questionnaire at 180 Days Post-treatment | Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment. | 180 days post-treatment |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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:
"Any Improvement" includes subjects assessed in categories 1-3. | At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment. | Posted | Number | percentage of participants improved | 60 days post-treatment |
|
|
|
| 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:
"Any Improvement" includes subjects assessed in categories 1-3. | 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. | Posted | Number | percentage of participants improved | 90 days post-treatment |
|
|
|
| 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:
"Any Improvement" includes subjects assessed in categories 1-3. | 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. | Posted | Number | percentage of participants improved | 180 days post-treatment |
|
|
|
| Secondary | Patient Satisfaction Questionnaire 90 Days Post-treatment | Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment. | 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. | Posted | Number | percentage of participants Satisfied | 90 days post-treatment |
|
|
|
| Secondary | Patient Satisfaction Questionnaire at 180 Days Post-treatment | Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment. | 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. | Posted | Number | percentage of participants Satisfied | 180 days post-treatment |
|
|
|
| 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. | 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. | Posted | Mean | Full Range | units on a scale | Average pain scores reported during study treatment |
|
|
|
| 0 |
| 68 |
| 5 |
| 68 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|