Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 35 - 60 |
Updated: | 11/25/2017 |
Start Date: | June 2011 |
End Date: | May 2012 |
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening 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.
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.
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.
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.
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
We found this trial at
1
site
9339 Genesee Avenue
San Diego, California 92121
San Diego, California 92121
Click here to add this to my saved trials