Lax SkinNCT06333067
Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
A study testing Sofwave in people with Lax Skin, run by Sofwave Medical LTD at 2 sites in United States.
Trial summary
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lax Skin
- What is being tested?
- Sofwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Oct 2023to 1 Nov 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male subjects between the ages 35-80.
- 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.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
- Able to understand and provide written Informed Consent.
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- 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
- 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- 2. Presence of any active systemic or local infections.
- 3. Presence of active local skin disease that may alter wound healing.
- 4. Severe solar elastosis.
- 5. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
- 6. History of chronic drug or alcohol abuse.
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- 7. Excessive subcutaneous fat on the cheeks.
- 8. Significant scarring in the area to be treated.
- 9. Severe or cystic facial acne, and/or Accutane use during past 6 months.
- 10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
- 11. Inability to understand the protocol or to provide a signed informed consent.
- 12. 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.
- 13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
- 14. 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Skin Wellness Dermatology Associates
Durham, North Carolina, 27713
Talasia Smith, (919) 294 9440, cst@skinwellnessdermatology.com
Brooke Jackson, MD
- Recruiting
Costal Skin & Eye Institute
La Mesa, California, 91942
Christopher V.Crosby, MD, research@coastalskineye.com
Christopher V.Crosby, MD
About this study
Official title: Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Read the detailed description
Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities.
All patients will return to the clinic for one follow-up visit at 3 months ± 2 weeks post last treatment (FU1).
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
- Conditions
- Lax Skin
- Being tested
- Sofwave
- Keywords
- neck zones., submental, Facial, Skin laxity
- Medical subject headings
- Cutis Laxa, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofwaveDevice
Also called SUPERB
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 |
|---|---|---|
| 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.
Improvement in the appearance of lax skin
Rate of improvement in the appearance of lax skin on the submental, neck zones and facial wrinkles following Sofwave treatments based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers.
Measured: 3 months 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 posted27 Mar 2024
- Study start11 Oct 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (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
- 100 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
- NCT06333067
- Sponsor's protocol ID
- Sofwave21
- Status last verified
- May 2025
- First submitted
- 20 Mar 2024
- Last updated
- 13 May 2025
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
- ClinicalTrials.gov ID
- NCT06333067
- Acronym / sponsor ID
- Sofwave21
- Conditions
- Lax Skin
- Keywords
- neck zones., submental, Facial, Skin laxity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Mar 2024 (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, multi-center, self-controlled clinical study with masked evaluation.
Detailed description
Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities.
All patients will return to the clinic for one follow-up visit at 3 months ± 2 weeks post last treatment (FU1).
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
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 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy female and male subjects between the ages 35-80.
- 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.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
Key exclusion criteria (14 listed)
- 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- 2. Presence of any active systemic or local infections.
- 3. Presence of active local skin disease that may alter wound healing.
- 4. Severe solar elastosis.
- 5. 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 |
|---|---|---|
| SofwaveAlso: SUPERBThe Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. | Device | lax tissue |
Primary outcome
Improvement in the appearance of lax skin
Time frame: 3 months post treatment follow-up visit
Rate of improvement in the appearance of lax skin on the submental, neck zones and facial wrinkles following Sofwave treatments based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers.
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 13 May 2025.
- 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.
2 sites 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, run by Sofwave Medical LTD at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Improvement in the appearance of lax skin (time frame: 3 months post treatment follow-up visit). 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 13 May 2025.