Facial WrinklesNCT07723664
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
A study testing SofWave in people with Facial Wrinkles and Jawline Contour, run by Sofwave Medical LTD at 1 site in United States.
Trial summary
Non-randomized single-arm prospective clinical study. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles, Jawline Contour, Skin Laxity
- What is being tested?
- SofWave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 15 Jul 2027
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male subjects between the ages 40-55.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
- Presence of mild to moderate laxity in the lower face and submental area.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
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- Able to understand and provide written Informed Consent.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
- Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
- Stable weight over the last 12 weeks and throughout the duration of the study.
- Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.
- Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.
- -
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Presence of any active systemic or local infections.
- Open wounds or lesions within the intended to treat area.
- Tattoo or former tattoo at or near treatment area.
- Presence of active local skin disease that may alter wound healing.
- Uncontrolled diabetes mellitus.
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- Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
- Severe solar elastosis.
- History of smoking in the past 10 years.
- History of chronic drug or alcohol abuse.
- Excessive subcutaneous fat on the cheeks.
- Significant scarring in the area to be treated or history of keloids.
- Severe or cystic facial acne, and/or Accutane use during the past 6 months.
- Pacemakers and electronic device implants in the treated area.
- Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
- Inability to understand the protocol or to provide a signed informed consent.
- History of cosmetic treatments in the area to be treated including:
- Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
- Injectable filler treatments in the past 6 months
- Injectable neuromodulator treatment in the past 4 months
- Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months.
- Taking anti-platelet or anti-coagulant within the past 2 weeks.
- Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks.
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dermatology & Laser Surgery Center
Houston, Texas, 77004
Paul Friedman, MD, 713-900-3900, drpaul@dermlasersurgery.com
Paul Friedman, MD
About this study
Non-randomized single-arm prospective clinical study.
Read the detailed description
Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).
- Conditions
- Facial Wrinkles, Jawline Contour, Skin Laxity
- Being tested
- SofWave
- Keywords
- lower face, upper neck, submental, facial wrinkles, jawline contour, skin laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofWaveDevice
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues
| Study group | Role | What they receive |
|---|---|---|
| Experimental: lax tissue | Experimental | Not described Receives: Device: SofWave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation
Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)
Measured: 12 weeks post treatment follow-up visit
Lower face and upper neck rejuvenation
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit.
Measured: 12 weeks post treatment follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofwave Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723664
- Sponsor's protocol ID
- SofWave31
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
- ClinicalTrials.gov ID
- NCT07723664
- Acronym / sponsor ID
- SofWave31
- Conditions
- Facial Wrinkles, Jawline Contour, Skin Laxity
- Keywords
- lower face, upper neck, submental, facial wrinkles, jawline contour, skin laxity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 23 Jul 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.
Non-randomized single-arm prospective clinical study.
Detailed description
Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: lax tissue | Experimental | Device: SofWave |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy female and male subjects between the ages 40-55.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
- Presence of mild to moderate laxity in the lower face and submental area.
Key exclusion criteria (25 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Presence of any active systemic or local infections.
- Open wounds or lesions within the intended to treat area.
- Tattoo or former tattoo at or near treatment area.
- Presence of active local skin disease that may alter wound healing.
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 |
|---|---|---|
| SofWaveThe Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues | Device | Experimental: lax tissue |
Primary outcome
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation
Time frame: 12 weeks post treatment follow-up visit
Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)
Lower face and upper neck rejuvenation
Time frame: 12 weeks post treatment follow-up visit
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit.
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 27 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SofWave in people with Facial Wrinkles and Jawline Contour, run by Sofwave Medical LTD 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 13 inclusion and 25 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 27 Jul 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.
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 Shlomit Mann, MSc (+972-4-7800268, Shlomit@sofwave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation (time frame: 12 weeks post treatment follow-up visit). The study lists 2 primary outcomes in all. 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 27 Jul 2026.