Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
|ClinicalTrials.gov Identifier: NCT01485107|
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Laxity of the décolleté||Device: Ulthera® System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||May 2012|
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
- Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post-treatment ]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 ]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 ]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 ]Based on Global Aesthetic Improvement Scale (GAIS) scores.
- Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ]Subject-completed questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|