Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Launched by ULTHERA, INC · Dec 2, 2011
Trial Information
Current as of June 06, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
FEMALE
Eligibility 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
About Ulthera, Inc
Ulthera, Inc. is a leading medical technology company specializing in non-invasive ultrasound solutions for aesthetic and therapeutic applications. Committed to advancing patient care through innovative research and development, Ulthera focuses on delivering safe and effective treatments that enhance skin lifting and tightening. The company’s flagship product, the Ultherapy system, utilizes ultrasound energy to stimulate collagen production and improve skin elasticity. By partnering with clinical researchers and practitioners, Ulthera aims to expand the understanding of ultrasound technology in dermatology and cosmetic procedures, ensuring high standards of safety and efficacy in all its offerings.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
Patients applied
Trial Officials
Michael Goldman, MD
Principal Investigator
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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