Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|