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
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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
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- 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.

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Ages Eligible for Study: | 35 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female, aged 35 to 60 years.
- Subject in good health.
- Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Scarring in areas to be treated.
- Tattoos in the areas to be treated.
- Patients with ports or defibrillators.
- Breast size >400cc each as measured by water displacement method.
- History of breast reduction surgery.
- Any open wounds or lesions in the area.
- Active and severe inflammatory acne in the region to be treated.
- Patients who have a history with keloid formation or hypertropic scarring

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 |
Responsible Party: | Ulthera, Inc |
ClinicalTrials.gov Identifier: | NCT01485107 History of Changes |
Other Study ID Numbers: |
ULT-105 |
First Posted: | December 5, 2011 Key Record Dates |
Last Update Posted: | November 24, 2017 |
Last Verified: | June 2013 |
Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System Ultherapy™ treatment Ulthera, Inc. Ultrasound treatment for skin tightening |
Additional relevant MeSH terms:
Cutis Laxa Skin Diseases, Genetic Genetic Diseases, Inborn Connective Tissue Diseases Skin Diseases |