Ultherapy™ Treatment Following Sculptra® Treatment

Not Applicable

Completed

Conditions: Skin Laxity

Interventions: Device: Ulthera® System
Other: Sculptra® treatment followed by Ultherapy™ treatment
Drug: Sculptra®

Registration Number: NCT01422538

Lead Sponsor: Ulthera, Inc

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ulthera® System	Subjects will receive Ulthera® System alone.
Group C	Sculptra® treatment followed by Ultherapy™ treatment	Sculptra® treatment followed by Ultherapy™ treatment
Group B	Sculptra®	Sculptra® only

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.
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.