A Prospective Pilot Study Comparing Immediate Combination Versus Sequential Treatment Using Injectable Poly-L-lactic Acid and Synchronous Ultrasound Parallel Beam Technology
Massachusetts General Hospital
Summary
Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later.
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 mo…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- Yes
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 a…
Interventions
- DeviceSofwave
parallel beam ultrasound on arm
- DrugSculptra
Sculptra injection into arm
Location
- Massachusetts General HospitalBoston, Massachusetts