Ultherapy™ Treatment Following Sculptra® Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment

Conditions
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Skin Laxity

Intervention / Treatment
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* Device: Ulthera® System
* Drug: Sculptra®
* Other: Sculptra® treatment followed by Ultherapy™ treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Subjects will receive Ulthera® System alone. | Device: Ulthera® System<br>* Focused ultrasound energy delivered below the surface of the skin on the lower face.<br>* Other names: Ultherapy™;|
| Active Comparator: Group B<br>Sculptra® only | Drug: Sculptra®<br>* 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.<br>* Other names: Poly-L-Lactic acid fillers;|
| Active Comparator: Group C<br>Sculptra® treatment followed by Ultherapy™ treatment | Other: Sculptra® treatment followed by Ultherapy™ treatment<br>* Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: = Very Much Improved = Much Improved = Improved = No Change = Worse Any Improvement includes subjects assessed in categories 1-3. | 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: = Very Much Improved = Much Improved = Improved = No Change = Worse Any Improvement includes subjects assessed in categories 1-3. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening, Skin laxity on the face and neck.