Lax SkinNCT07685821
In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment
A study testing Sofwave in people with Lax Skin and Improve Facial Wrinkles, run by Sofwave Medical LTD at 1 site in United States.
Trial summary
Open-label, non-randomized single-arm prospective, single-center, self-controlled clinical study. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lax Skin, Improve Facial Wrinkles
- What is being tested?
- Sofwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to Dec 2026
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male subjects between the ages 35-60
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
- Willing to give biopsies.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements (including providing biopsies).
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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.
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.
- Presence of active local skin disease that may alter wound healing.
- Severe solar elastosis.
- Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
- History of chronic drug or alcohol abuse.
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- Excessive subcutaneous fat on the cheeks.
- Significant scarring in the area to be treated.
- Severe or cystic facial acne, and/or Accutane use during past 6 months.
- 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 facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant 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.
United States1 site
Dermatology Cosmetic Laser Associates of La Jolla, Inc
San Diego, California, 92121
About this study
Open-label, non-randomized single-arm prospective, single-center, self-controlled clinical study.
Read the detailed description
Eligible subjects will arrive for a screening visit, and if will be found eligible and will provide signed ICF, during this visit a biopsy will be taken from the pre-auricular area.
At the second visit, a week after the screening visit, sutures from the biopsy (if present) will be removed, and subjects will receive a single treatment on the full face, neck, and submental area using the SofWave system with the Lift applicator.
Subjects will return to the clinic for a follow-up visit at one of the following timepoints (2 subjects per timepoint): 5 days, 4 weeks ± 2 days, 8 weeks ± 2 days, 12 weeks ± 4 days, or 24 weeks ± 4 days post-treatment. During this visit, an additional biopsy will be taken from the opposite pre-auricular side to that used at the screening visit.
All subjects will arrive for an additional visit, a week after the follow-up visit, for suture removal (if will exist).
- Conditions
- Lax Skin, Improve Facial Wrinkles
- Being tested
- Sofwave
- Keywords
- wrinkles, Lax Skin, Neck, Submental, Lifting
- 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. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.
| Study group | Role | What they receive |
|---|---|---|
| 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 biological responses
Evaluate the biological responses of tissue inflammation, proliferation and remodeling via fibroblast stimulation following SofWave single treatment. Tissue biological responses will be correlated with the patients' skin laxity and global aesthetic improvement.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start22 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lax SkinStudies 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
- 10 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
- NCT07685821
- Sponsor's protocol ID
- SofWave28
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment
- ClinicalTrials.gov ID
- NCT07685821
- Acronym / sponsor ID
- SofWave28
- Conditions
- Lax Skin, Improve Facial Wrinkles
- Keywords
- wrinkles, Lax Skin, Neck, Submental, Lifting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 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.
Open-label, non-randomized single-arm prospective, single-center, self-controlled clinical study.
Detailed description
Eligible subjects will arrive for a screening visit, and if will be found eligible and will provide signed ICF, during this visit a biopsy will be taken from the pre-auricular area.
At the second visit, a week after the screening visit, sutures from the biopsy (if present) will be removed, and subjects will receive a single treatment on the full face, neck, and submental area using the SofWave system with the Lift applicator.
Subjects will return to the clinic for a follow-up visit at one of the following timepoints (2 subjects per timepoint): 5 days, 4 weeks ± 2 days, 8 weeks ± 2 days, 12 weeks ± 4 days, or 24 weeks ± 4 days post-treatment. During this visit, an additional biopsy will be taken from the opposite pre-auricular side to that used at the screening visit.
All subjects will arrive for an additional visit, a week after the follow-up visit, for suture removal (if will exist).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lax tissue | Experimental | Device: Sofwave |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy female and male subjects between the ages 35-60
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
- Willing to give biopsies.
Key exclusion criteria (14 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.
- Presence of active local skin disease that may alter wound healing.
- Severe solar elastosis.
- Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
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. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. | Device | lax tissue |
Primary outcome
Evaluate the biological responses
Time frame: up to 24 weeks
Evaluate the biological responses of tissue inflammation, proliferation and remodeling via fibroblast stimulation following SofWave single treatment. Tissue biological responses will be correlated with the patients' skin laxity and global aesthetic improvement.
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 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Lax Skin and Improve Facial Wrinkles, 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the biological responses (time frame: up to 24 weeks). 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 8 Jul 2026.