Skin Laxity
Conditions
Keywords
Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening, Skin laxity on the face and neck.
Brief summary
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Detailed description
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.
Interventions
DEVICEUlthera® System
Focused ultrasound energy delivered below the surface of the skin on the lower face.
DRUGSculptra®
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.
OTHERSculptra® treatment followed by Ultherapy™ treatment
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
Sponsors
Ulthera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 35 to 60 years. * Subject in good health. * Skin laxity in the lower face and neck. * Grade 1 and 2 on the Knize Scale
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 and neck. * Excessive skin laxity on the face and neck. * No scarring in areas to be treated. * Any open facial wounds or lesions. * Acne on the face. * Patients who have a history with keloid formation or hypertropic scarring * Patients who have a hypersensitivity to injectable poly-L-lactic acid * Presence of a metal stent or implant in the facial area to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. | 90 days post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Aesthetic Improvement 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) (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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3. |
| Overall Aesthetic Improvement 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) (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: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse Any Improvement includes subjects assessed in categories 1-3. |
| Subject Satisfaction at 90 Days Post-treatment | 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. |
| Subject Satisfaction at 180 Days Post-treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject's Assessment of Pain | During Ulthera study treatment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group A Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed). | 10 |
| Group B Subjects received Sculptra® treatment only | 10 |
| 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). | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Missed visit | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Group C | Group B | Group A |
|---|---|---|---|---|
| Age, Continuous | 48 years | 50 years | 47 years | 47 years |
| Fitzpatrick Skin Type Type 1 | 1 participants | 1 participants | 0 participants | 0 participants |
| Fitzpatrick Skin Type Type II | 16 participants | 6 participants | 6 participants | 4 participants |
| Fitzpatrick Skin Type Type III | 12 participants | 3 participants | 4 participants | 5 participants |
| Fitzpatrick Skin Type Type IV | 0 participants | 0 participants | 0 participants | 0 participants |
| Fitzpatrick Skin Type Type V | 0 participants | 0 participants | 0 participants | 0 participants |
| Fitzpatrick Skin Type Type VI | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized African American/Black | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 28 participants | 9 participants | 10 participants | 9 participants |
| Race/Ethnicity, Customized Native Amer. Indian/ Alaskan Native | 1 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 30 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 25 Participants | 8 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 90 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. | 40 percentage of participants improved |
| Group B | Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. | 30 percentage of participants improved |
| Group C | Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. | 33 percentage of participants improved |
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: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Overall Aesthetic Improvement at 180 Days Post-treatment | SGAIS - Improved to Very Much Improved | 70 percentage of participants improved |
| Group A | Overall Aesthetic Improvement at 180 Days Post-treatment | PGAIS - Improved to Very Much Improved | 30 percentage of participants improved |
| Group B | Overall Aesthetic Improvement at 180 Days Post-treatment | PGAIS - Improved to Very Much Improved | 33 percentage of participants improved |
| Group B | Overall Aesthetic Improvement at 180 Days Post-treatment | SGAIS - Improved to Very Much Improved | 44 percentage of participants improved |
| Group C | Overall Aesthetic Improvement at 180 Days Post-treatment | PGAIS - Improved to Very Much Improved | 43 percentage of participants improved |
| Group C | Overall Aesthetic Improvement at 180 Days Post-treatment | SGAIS - Improved to Very Much Improved | 43 percentage of participants improved |
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: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Overall Aesthetic Improvement at 90 Days Post-treatment | PGAIS - Improved to Very Much Improved | 50 percentage of participants improved |
| Group A | Overall Aesthetic Improvement at 90 Days Post-treatment | SGAIS - Improved to Very Much Improved | 70 percentage of participants improved |
| Group B | Overall Aesthetic Improvement at 90 Days Post-treatment | SGAIS - Improved to Very Much Improved | 60 percentage of participants improved |
| Group B | Overall Aesthetic Improvement at 90 Days Post-treatment | PGAIS - Improved to Very Much Improved | 60 percentage of participants improved |
| Group C | Overall Aesthetic Improvement at 90 Days Post-treatment | PGAIS - Improved to Very Much Improved | 67 percentage of participants improved |
| Group C | Overall Aesthetic Improvement at 90 Days Post-treatment | SGAIS - Improved to Very Much Improved | 56 percentage of participants improved |
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.
Time frame: 180 days post-treatment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Subject Satisfaction at 180 Days Post-treatment | 70 percentage of participants Satisfied |
| Group B | Subject Satisfaction at 180 Days Post-treatment | 63 percentage of participants Satisfied |
| Group C | Subject Satisfaction at 180 Days Post-treatment | 38 percentage of participants Satisfied |
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.
Time frame: 90 days post-treatment.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Subject Satisfaction at 90 Days Post-treatment | 70 percentage of participants Satisfied |
| Group B | Subject Satisfaction at 90 Days Post-treatment | 60 percentage of participants Satisfied |
| Group C | Subject Satisfaction at 90 Days Post-treatment | 78 percentage of participants Satisfied |
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.
Time frame: During Ulthera study treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group A | Subject's Assessment of Pain | Cheek | 4.5 units on a scale |
| Group A | Subject's Assessment of Pain | Submental | 2.9 units on a scale |
| Group A | Subject's Assessment of Pain | Submandibular | 3.9 units on a scale |
| Group B | Subject's Assessment of Pain | Cheek | 4.5 units on a scale |
| Group B | Subject's Assessment of Pain | Submental | 2.9 units on a scale |
| Group B | Subject's Assessment of Pain | Submandibular | 3.3 units on a scale |