Treatment for Lifting Upper Arm Lax Skin (NCT05358327) | Clinical Trial Compass
CompletedNot Applicable
Treatment for Lifting Upper Arm Lax Skin
United States50 participantsStarted 2022-05-01
Plain-language summary
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Who can participate
Age range
35 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects \> 35 years of age and \< 70 years of age.
. Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
. Desire to undergo upper arms skin lax lifting treatments.
. Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
. Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
. Willing to have research photos taken of treatment areas.
. Subject agrees not to undergo any other upper arm skin lax treatments for a period of 3 months following Sofwave treatment.
Exclusion criteria
. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
. Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.).
. History of Epileptic seizures.
. Known allergy to lidocaine or epinephrine or antibiotics.
. Active malignancy or history of malignancy in the past 5 years.
. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.