New study tests One-Visit skin tightening combo for sagging arms
NCT ID NCT07342452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two ways to treat aging skin on the upper arms: getting Sculptra injections and Sofwave ultrasound on the same day, versus getting Sofwave first and Sculptra a month later. About 13 adults aged 40 and older with moderate to severe skin looseness will take part. The goal is to see which timing works better for improving skin tightness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female subjects ≥ 40 years old 2. Able to provide informed consent 3. Baseline level of upper arm skin flaccidity and volume loss as defined as type III or greater on the Arm Visual Analog Scale (Arm VAS) for aging Exclusion Criteria: * Prior treatment to the arms with a biostimulatory agent, energy-based device, or skin-tightening device within the past year. * History of dermabrasion or deep peels involving the upper arms within the past year. * History of prior surgery involving the upper arms. * History of prior fat reduction procedures within the upper arms. * History of keloids, hypertrophic scarring, or connective tissue disorders. * Active dermatologic condition involving the treatment site. * Active systemic or local infection or wounds at treatment site. * History of lymphatic drainage problems involving the upper arms. * Excessive subcutaneous fat in the upper arms as judged per the investigator. * Use of immunosuppressive or anticoagulant/antiplatelet medications. * Uncontrolled medical conditions interfering with wound healing or impacting bleeding. * Use of weight loss medications or supplements within the month before the baseline visit. * BMI ≥ 30 kg/m². * Non-stable weight (\>5% change) during the month prior to enrollment. * Uncontrolled or current hormonal imbalance, including thyroid, pituitary, or androgen-related disorders. * History of malignancy during the past 5 years. * Implanted devices, such as pacemaker or defibrillator. * Active pregnancy, recent pregnancy within the past 3 months, planning to become pregnant during the study period, and/or breastfeeding. * History of heavy smoking during the past 10 years. * History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study procedures. * Known allergy to any topical anesthetics or PLLA. * Presence of metal implants or metallic foreign bodies within the treatment area (upper arms).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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