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Ultrasound Therapy
Sofwave for Loose Skin
N/A
Waitlist Available
Research Sponsored by Goldman, Butterwick, Fitzpatrick and Groff
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two treatments, Sofwave® and Ultherapy®, for tightening loose skin on the upper inner arms. Sofwave® uses sound waves, while Ultherapy® uses ultrasound energy. The study aims to see which method is more effective for individuals with loose skin in this area.
Eligible Conditions
- Loose Skin
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening to three months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to three months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physician Global Aesthetic Improvement Scale (PGAIS)
Upper Arm Circumference
Upper Arm Elasticity
+2 moreSecondary study objectives
Dyspigmentation
Edema
Erythema
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: UltherapyExperimental Treatment1 Intervention
Group II: SofwaveExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofwave
2020
Completed Phase 3
~240
Ultherapy
2014
N/A
~10
Find a Location
Who is running the clinical trial?
Sofwave Medical LTDIndustry Sponsor
9 Previous Clinical Trials
557 Total Patients Enrolled
Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
31 Previous Clinical Trials
649 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received any experimental treatment for loose or wrinkled skin on your upper arms within the past year.You are currently taking medication that weakens your immune system or have an autoimmune disease.You cannot use any creams, cosmetics, or home remedies to improve or treat loose skin for four weeks before starting the study treatment.You have scars in the areas where the treatment will be done.You have a history of bleeding or clotting problems.You need to continue your normal habits of being outside in the sun, eating your regular diet, and staying physically active throughout the study.You have used spray tans or sunless tanners on the areas that will be treated in the study within the past four (4) weeks.You have wounds in the area being treated that haven't fully healed yet.The skin on the upper inner arm becomes tighter and looks better when it is stretched or lifted upwards.You have a history of blood clotting in both of your arms or any other blood vessel disorder in your arms.You have received certain cosmetic treatments or surgeries in the past year, such as injections, laser treatments, or surgery for body contouring.You have a skin condition in the area being treated that could make it difficult to assess the study properly.
Research Study Groups:
This trial has the following groups:- Group 1: Sofwave
- Group 2: Ultherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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