Skin AgingPhase 4NCT07342452
Randomized Trial of Combination Treatment With Sofwave and Sculptra
A Phase 4 study testing Sofwave and Sculptra in people with Skin Aging, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Sofwave and Sculptra
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to 1 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Margaret Chou, MD contact
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Molly Wanner, MD, 617-643-3885, mwanner@partners.org
Margaret Chou, MD, mchou3@mgh.harvard.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Sofwave, Sculptra
- Keywords
- Laxity, Skin, Arm, Sofwave, Sculptra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofwaveDevice
parallel beam ultrasound on arm
SculptraDrug
Sculptra injection into arm
| Study group | Role | What they receive |
|---|---|---|
| Sofwave and Sculptra same day | Active comparator | Not described Receives: Device: Sofwave; Drug: Sculptra |
| Sofwave and Sculptra one month apart | Active comparator | Not described Receives: Device: Sofwave; Drug: Sculptra |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAIS skin laxity
5-graded scale: worse; no change; improved; much improved; or very much improved.
Measured: From treatment to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startJan 2027 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly A. Wanner, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342452
- Sponsor's protocol ID
- 2025P003217
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study Comparing Immediate Combination Versus Sequential Treatment Using Injectable Poly-L-lactic Acid and Synchronous Ultrasound Parallel Beam Technology
- ClinicalTrials.gov ID
- NCT07342452
- Acronym / sponsor ID
- 2025P003217
- Conditions
- Skin Aging
- Keywords
- Laxity, Skin, Arm, Sofwave, Sculptra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sofwave and Sculptra same day | Active comparator | Device: Sofwave, Drug: Sculptra |
| Sofwave and Sculptra one month apart | Active comparator | Device: Sofwave, Drug: Sculptra |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofwaveparallel beam ultrasound on arm | Device | Sofwave and Sculptra one month apart, Sofwave and Sculptra same day |
| SculptraSculptra injection into arm | Drug | Sofwave and Sculptra one month apart, Sofwave and Sculptra same day |
Primary outcome
GAIS skin laxity
Time frame: From treatment to 3 months after treatment
5-graded scale: worse; no change; improved; much improved; or very much improved.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Related trials for Skin Aging
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Enrolling by invitationEarly Phase 1
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
Aging
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
RecruitingPhase 3
Safety and Effectiveness of NOA HYDRATION Injectable Gel for the Improvement of Skin Quality Including Attributes Such as Skin Smoothness
Skin Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret Chou, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofwave and Sculptra in people with Skin Aging, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Wanner, MD (6176433885, mwanner@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAIS skin laxity (time frame: From treatment to 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.