NCT01735929WithdrawnNot Applicable
Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwestern University
- Primary Endpoint
- Change from baseline in photo ratings at 8 weeks.
Study Overview
Brief Summary
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women 35-60 years old
- •Exhibit mild to moderate neck skin laxity on clinical examination
- •No other serious health problems, including psychiatric illness.
Exclusion Criteria
- •Prior neck surgery or face lift.
- •Bleeding disorders or coagulopathy.
- •Botulinum toxin or filler injections to neck area within past 6 months.
- •Severe neck skin laxity or sagging
- •Other serious medical conditions that in the opinion of the surgeon could compromise safety
Arms & Interventions
Neck Liposuction and Ultrasound Treatment
Experimental
Subject will receive neck liposuction and ultrasound treatment.
Intervention: Neck Liposuction and Ultrasound Treatment (Procedure)
Sham
Sham Comparator
Subject will receive sham treatment
Intervention: Sham Treatment (Procedure)
Outcomes
Primary Outcomes
Change from baseline in photo ratings at 8 weeks.
Time Frame: Baseline and 8 weeks
Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.
Secondary Outcomes
No secondary outcomes reported
Investigators
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
Northwestern University
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