Status:
COMPLETED
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Lead Sponsor:
Ulthera, Inc
Conditions:
Skin Laxity of the décolleté
Eligibility:
FEMALE
35-60 years
Phase:
NA
Brief Summary
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 stud...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01485107
Start Date
June 1 2011
End Date
May 1 2012
Last Update
November 24 2017
Active Locations (1)
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1
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
San Diego, California, United States, 92121