Sculptra + Sofwave for Skin Aging

Overseen By Margaret Chou, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Keloids, Infections, BMI ≥ 30, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two treatments, Sculptra and Sofwave (a non-invasive ultrasound treatment), for tightening and enhancing the appearance of skin on the upper arms. It compares administering both treatments on the same day versus spacing them a month apart. Individuals with noticeable loose skin or volume loss on their upper arms may qualify. However, those who have undergone certain treatments or surgeries on their arms or have specific health conditions are not eligible. As a Phase 4 trial, this research seeks to understand how these FDA-approved and effective treatments can benefit more patients.

What is the safety track record for Sculptra and Sofwave?

Past studies have shown that Sculptra is well-tolerated and effectively reduces facial wrinkles and lines. Patients reported mild side effects, such as redness or swelling, which usually resolve quickly. Sofwave, used to lift and tighten skin, has also demonstrated a good safety profile. It may cause temporary redness or swelling, but these effects are generally mild.

When combined, these treatments aim to improve skin appearance by addressing different signs of aging. Both treatments have FDA approval for similar uses, which supports their safety. Overall, they appear safe for most people when used as directed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Sculptra and Sofwave for skin aging because it merges two innovative approaches to rejuvenate skin. Sculptra is a collagen stimulator that works from within by gradually rebuilding the skin's structural foundation, while Sofwave uses ultrasound technology to lift and tighten skin through non-invasive means. This combination is distinct because it could provide both immediate tightening and long-term volumizing effects, potentially offering a more comprehensive anti-aging solution compared to traditional options like topical retinoids or invasive procedures. Additionally, exploring the timing of these treatments—whether on the same day or spaced a month apart—could optimize results and offer more flexibility for patients.

What evidence suggests that this trial's treatments could be effective for skin aging?

This trial will compare two approaches to using Sofwave and Sculptra for reducing signs of skin aging. Research has shown that Sofwave, which tightens and tones loose skin, can lead to noticeable improvements within three months after just one treatment. Sculptra, in contrast, boosts collagen production to restore skin fullness. In this trial, one group will receive Sofwave and Sculptra on the same day, while another group will receive them one month apart. Together, these treatments effectively lift, tone, and add volume to the skin, offering both immediate and long-lasting effects. This combination has become a new standard for non-surgical skin treatments. ^{3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women over 40 with a certain level of upper arm skin sagging and volume loss. Participants must be able to consent, not have implanted devices like pacemakers, no recent or current pregnancy, non-smokers for the last decade, no metal in arms, stable weight recently, and no history of certain treatments or conditions that affect the skin.

Inclusion Criteria

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

Able to provide informed consent

I am 40 years old or older.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either immediate combination therapy with Sculptra and Sofwave on the same day or sequential therapy with Sculptra followed by Sofwave one month later

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including standardized digital photographs and video of snap test

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sculptra
• Sofwave

Trial Overview

The study tests two anti-aging treatments on the upper arm: Sculptra and Sofwave. One group receives both treatments on the same day while another gets Sofwave first followed by Sculptra a month later. The goal is to see which sequence works better for skin aging.

How Is the Trial Designed?

Group I: Sofwave and Sculptra one month apart Active Control 2 Interventions

Group II: Sofwave and Sculptra same day Active Control 2 Interventions

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1.

aesthetics.com

aesthetics.com/blog/sofwave-sculptra-anti-aging-treatment-combo/

Sofwave™ & Sculptra® Combo for Anti-Aging | Louisville KY

The combination of Sofwave™ and Sculptra® creates a synergistic effect, treating aging skin from multiple angles. It provides both volume ...

2.

sofwave.com

sofwave.com/patients/before-after

Sofwave Before and After Real Treatment Results.

See the proven results of Sofwave™ for yourself. FDA-cleared, non-invasive, safe, and effective technology for improving skin laxity, lifting, and toning.

3.

advdermatology.com

advdermatology.com/cosmetic-procedures/non-surgical-facelift/sofwave/

Sofwave Facial Treatment & Side Effects for Face, Neck

At 3 months, a majority of patients were marked as improved to very much improved following a single treatment session only. 72% of the patients were satisfied ...

4.

sofwave.com

sofwave.com/blog/the-sofwave-got-lift-efect

Real Patient Stories and Social Media Testimonials

The combination of immediate results, minimal discomfort and downtime, and long-lasting outcomes has created a new standard in skin lifting ...

5.

ctv.veeva.com

ctv.veeva.com/study/randomized-trial-of-combination-treatment-with-sofwave-and-sculptra

Randomized Trial of Combination Treatment With Sofwave ...

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

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf3/P030050S039B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

The original PMA (P030050) was approved on August 3, 2004 and is indicated for restoration and/or correction of the signs of facial fat loss ...

7.

jddonline.com

jddonline.com/articles/effectiveness-and-safety-of-sculptra-poly-l-lactic-acid-injectable-implant-in-the-correction-of-cheek-wrinkles-S1545961624P1297X/

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid ...

Conclusion: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04146584

Safety and Efficacy of SofWave Treatment to Lift Lax Tissue ...

Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician.