Randomized Trial of Combination Treatment With Sofwave and Sculptra

Starting soon · Phase 4

Conditions studied: Skin Aging

In brief

Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later.

Key facts

Study ID

NCT07342452

Run by

Massachusetts General Hospital

People needed

13

Starts

2026-07-01

Expected to finish

2027-04-01

Last updated by the study team

2026-05-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects ≥ 40 years old
• Able to provide informed consent
• 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

You may not qualify if…

• 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).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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