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
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Subjects will receive Ulthera® System alone. |
|
| Group B | Active Comparator | Sculptra® only |
|
| Group C | Active Comparator | Sculptra® treatment followed by Ultherapy™ treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera® System | Device | Focused ultrasound energy delivered below the surface of the skin on the lower face. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. | Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm. | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Aesthetic Improvement at 90 Days Post-treatment | At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Assessment of Pain | Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only. | During Ulthera study treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jay Burns, MD | EpiCentre Park Lane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EpiCentre Park Lane | Dallas | Texas | 75231 | United States |
Thirty subjects were enrolled and thirty subjects were treated in the study. The first subject was treated on June 28, 2011; the last subject was treated on March 28, 2012. The last patient follow-up for the trial was September 24, 2012.
Thirty subjects were assigned to three treatment groups. Subjects NOT willing to pay for Sculptra were assigned to Treatment Group A. Subjects willing to pay for Sculptra were randomly assigned to either Treatment Group B or Treatment Group C.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Subjects received Ultherapy® Treatment only. |
| FG001 | Group B | Subjects received Sculptra® treatment only |
| FG002 | Group C | Subjects received Sculptra® treatment and Ultherapy® treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed). |
| BG001 | Group B |
| 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 | Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. | Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm. | 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 | Group A | Subjects received Ultherapy® Treatment only. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
Not provided
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C482305 | New-Fill |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sculptra® | Drug | Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart. |
|
|
| Sculptra® treatment followed by Ultherapy™ treatment | Other | Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra. |
|
| 90 days post-treatment. |
| Overall Aesthetic Improvement at 180 Days Post-treatment | At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
| 180 days post-treatment |
| Subject Satisfaction at 90 Days Post-treatment | Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated. | 90 days post-treatment. |
| Subject Satisfaction at 180 Days Post-treatment | Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated. | 180 days post-treatment |
Subjects received Sculptra® treatment only
| BG002 | Group C | Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed). |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| OG002 | Group C | Subjects received Sculptra® treatment and Ultherapy® treatment |
|
|
| Secondary | Overall Aesthetic Improvement at 90 Days Post-treatment | At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
| Posted | Number | percentage of participants improved | 90 days post-treatment. |
|
|
|
| Secondary | Overall Aesthetic Improvement at 180 Days Post-treatment | At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
| Posted | Number | percentage of participants improved | 180 days post-treatment |
|
|
|
| Other Pre-specified | Subject's Assessment of Pain | Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only. | Posted | Mean | Full Range | units on a scale | During Ulthera study treatment |
|
|
|
| Secondary | Subject Satisfaction at 90 Days Post-treatment | Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated. | Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied or Satisfied. | Posted | Number | percentage of participants Satisfied | 90 days post-treatment. |
|
|
|
| Secondary | Subject Satisfaction at 180 Days Post-treatment | Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated. | Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied. | Posted | Number | percentage of participants Satisfied | 180 days post-treatment |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Group B | Subjects received Sculptra® only. | 0 | 10 | 0 | 10 |
| EG002 | Group C | Subjects received Sculptra® and Ultherapy® Treatment. | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
|
|
| Submandibular |
|