IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
This study has been completed.
Sponsor:
Ulthera, Inc
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01485107
First received: December 1, 2011
Last updated: June 27, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Skin Laxity of the décolleté | Device: Ulthera® System |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Ulthera, Inc:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 24 |
| Study Start Date: | June 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 35 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485107
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485107
Locations
| United States, California | |
| Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser | |
| San Diego, California, United States, 92121 | |
Sponsors and Collaborators
Ulthera, Inc
Investigators
| Principal Investigator: | Michael Goldman, MD | Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser |
More Information
| Responsible Party: | Ulthera, Inc |
| ClinicalTrials.gov Identifier: | NCT01485107 History of Changes |
| Other Study ID Numbers: |
ULT-105 |
| Study First Received: | December 1, 2011 |
| Last Updated: | June 27, 2013 |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on June 26, 2017