Randomized Trial of Combination Treatment With Sofwave and Sculptra

A Prospective Pilot Study Comparing Immediate Combination Versus Sequential Treatment Using Injectable Poly-L-lactic Acid and Synchronous Ultrasound Parallel Beam Technology

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

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Device: Sofwave; Drug: Sculptra

Detailed Description

This is a prospective, single site, split-body, intra-individual comparison pilot study. Each subject serves as their own control. 13 subjects will be recruited for a goal of treatment 10 subjects. One upper extremity (proximal medial arm) will be randomized to receive immediate combination therapy with both injectable poly-L-lactic acid (PLLA, Sculptra®) and synchronous ultrasound parallel beam technology (Sofwave™) administered over the same day. The contralateral arm will undergo sequential therapy, with PLLA administered at baseline and synchronous ultrasound parallel beam treatment one month later (Treatment Visit #2, Day 30).

The study employs a randomized, split-body design to minimize inter-patient variability, with blinded investigator assessment of efficacy outcomes through assessment of standardized digital photographs and video of snap test (skin turgor test). taken during the Final Visit (Day 120).

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Molly Wanner, MD; Phone Number: 6176433885; Email: mwanner@partners.org
• Study Contact Backup: Name: Margaret Chou, MD; Email: mchou3@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Margaret Chou, MD; Email: mchou3@mgh.harvard.edu
      • Contact: Molly Wanner, MD; Phone Number: 617-643-3885; Email: mwanner@partners.org
      • Principal Investigator: Molly Wanner, MD
      • Sub-Investigator: Margaret Chou, MD
      • Sub-Investigator: Bridget Myers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sofwave and Sculptra same day	Device: Sofwave; parallel beam ultrasound on arm; Drug: Sculptra; Sculptra injection into arm
Active Comparator: Sofwave and Sculptra one month apart	Device: Sofwave; parallel beam ultrasound on arm; Drug: Sculptra; Sculptra injection into arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAIS skin laxity	5-graded scale: worse; no change; improved; much improved; or very much improved.	From treatment to 3 months after treatment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Laxity, Skin, Arm, Sofwave, Sculptra
• Additional Relevant MeSH Terms: New-Fill
• Other Study ID Numbers: 2025P003217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes