NCT07342452

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Skin Aging

Interventions

Type	Name	Description
DEVICE	Sofwave	parallel beam ultrasound on arm
DRUG	Sculptra	Sculptra injection into arm

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study