Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté|
- Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
- Skin Laxity of the Décolleté [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.
- Bilateral chest measurements [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.
- Overall aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]Based on Global Aesthetic Improvement Scale (GAIS) scores.
- Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]Subject-completed questionnaire.
|Study Start Date:||June 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy™ treatment on the décolleté
All enrolled subjects will receive the study treatment.
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy™ treatment
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485107
|United States, California|
|Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser|
|San Diego, California, United States, 92121|
|Principal Investigator:||Michael Goldman, MD||Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser|