Upper Arm Treatment for Muscle Tone and Skin Appearance
Sofwave and Pure Impact
Connective Tissue Diseases+4
+ Cutis Laxa
+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Treatment Study
Summary
Study start date: August 5, 2024
Actual date on which the first participant was enrolled.This study explores a new way to improve the appearance of loose skin and tone muscles in the upper arms. It involves a combination of two treatments, SofWave and Pure Impact. SofWave is typically known for its ability to tighten skin using ultrasound technology, while Pure Impact focuses on muscle toning. The study is looking at how well these treatments work together to address common concerns about skin laxity and muscle tone in the arms, which can be a significant issue for many people. Understanding the effectiveness of this treatment combination could lead to better options for those seeking to enhance their appearance in this area. Participants in the study will receive treatments on both of their upper arms. They will undergo one or two SofWave sessions and four Pure Impact treatments. The treatments may happen on the same day or on different days, depending on the schedule that works best. Pure Impact is always applied before SofWave if done on the same day. After completing all treatments, participants will have two follow-up visits, one approximately a month later and another around three months later. These visits help researchers assess the effectiveness of the treatment combination over time. The study's design ensures that participants are monitored regularly to check the safety and effectiveness of the treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 25 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Tennessee Clinical Research Center
Nashville, United StatesOpen Tennessee Clinical Research Center in Google Maps