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
1 other identifier
interventional
13
1 country
1
Brief Summary
Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2026
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 15, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
January 15, 2026
January 1, 2026
1 year
January 5, 2026
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GAIS skin laxity
5-graded scale: worse; no change; improved; much improved; or very much improved.
From treatment to 3 months after treatment
Study Arms (2)
Sofwave and Sculptra same day
ACTIVE COMPARATORSofwave and Sculptra one month apart
ACTIVE COMPARATORInterventions
Eligibility Criteria
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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dermatologist
Study Record Dates
First Submitted
January 5, 2026
First Posted
January 15, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01