New study tests One-Visit skin tightening combo for sagging arms

NCT ID NCT07342452

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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