Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
Overview
- Phase
- N/A
- Intervention
- Ulthera® System
- Conditions
- Skin Laxity
- Sponsor
- Ulthera, Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group A
Subjects will receive Ulthera® System alone.
Intervention: Ulthera® System
Group B
Sculptra® only
Intervention: Sculptra®
Group C
Sculptra® treatment followed by Ultherapy™ treatment
Intervention: Sculptra® treatment followed by Ultherapy™ treatment
Outcomes
Primary Outcomes
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
Time Frame: 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 Outcomes
- Overall Aesthetic Improvement at 180 Days Post-treatment(180 days post-treatment)
- Subject Satisfaction at 180 Days Post-treatment(180 days post-treatment)
- Overall Aesthetic Improvement at 90 Days Post-treatment(90 days post-treatment.)
- Subject Satisfaction at 90 Days Post-treatment(90 days post-treatment.)