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Sofwave for Loose Skin
Study Summary
This trial will compare the effects of two different medical devices on the upper inner arms of subjects.
- Loose Skin
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Sofwave
- Group 2: Ultherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is there an age restriction on enrollment for this experiment?
"Acceptance into this medical experiment is contingent upon participants being between 35 and 70 years of age."
What goals is this research endeavor striving to achieve?
"The Physician Global Aesthetic Improvement Scale (PGAIS) is employed as the primary performance metric in this trial, measuring outcomes from Screening to Three Months Post-Treatment. The secondary objectives are related to Dyspigmentation, Subject Satisfaction Questionnaire, and Ulceration/Erosion; each of which will be evaluated through a Treating Investigator Evaluation."
Has recruitment commenced for this trial yet?
"Affirmative. According to clinicaltrials.gov, recruitment for this trial is ongoing; it was first published on April 14th 2022 and the most recent update occurred on April 27th of the same year. The study aims to recruit a total of 15 patients from one site."
Do I meet the qualifications for participation in this experiment?
"This clinical trial is seeking 15 adults aged between 35 and 70 with loose skin on the inner arm. Applicants must satisfy these requirements: (a) Male or female participants older than 35 years but younger than 70, (b) In good physical condition based on investigator's assessment and medical history, (c) Upper inside of forearm laxity that improves when pulled up, moderately to severely crepey/flaccid epidermis according to the Upper Inner Arm Visual Crepiness/Laxity Scoring Framework detailed in Appendix B;(d) Willingness to sign an informed consent form as well as a photographic release document"
How many individuals are being admitted to this experiment?
"Affirmative. The clinical trial is actively enrolling participants, according to the information available on clinicaltrials.gov. This research endeavour was initially posted on April 14th 2022 and last modified on April 27th 2022; it requires 15 subjects from a single location for completion."
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