Title
Ultherapy™ Treatment Following Sculptra® Treatment
Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
Phase
N/ALead Sponsor
UltheraStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Skin LaxityIntervention/Treatment
polylactic acid ...Study Participants
30This 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.
Focused ultrasound energy delivered below the surface of the skin on the lower face.
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® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
Sculptra® treatment followed by Ultherapy™ treatment
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.
| Event Type | Organ System | Event Term |
|---|
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.
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.
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.
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.
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.
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.
