RhytidesNCT06104514
Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
A study testing Sofwave in people with Rhytides and Wrinkle, run by Sofwave Medical LTD at 6 sites in United States.
Trial summary
Open-label, non-randomized, prospective, multi-center, self-controlled Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Sofwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jul 2023to 12 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- Desire to improve the peri-oral appearance, decrease the distance between the nose and the upper lip (Philtral column length) and/or reduce the peri-oral rhytids.
- Philtral column height>15mm or/and has moderate severe perioral rhytids.
- Subject agrees to maintain a stable weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study.
- 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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- Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
- Agree not to undergo any other facial treatments for a period of 3 months following SofWave treatments.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
- Melanoma active malignancy or history of malignancy in the past 5 years.
- Any other non-melanoma malignancy active malignancy or history of malignancy in the past 5 years within the intended to treat area.
- Previous chemotherapy treatments.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
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- History of chronic drug or alcohol abuse
- History of Epileptic seizures.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
- History of significant lymphatic drainage problems within the facial areas.
- History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- Excessive subcutaneous fat on the face.
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-coagulant within the past 2 weeks
- Currently taking or has taken diet pills or weight control supplements within the past month.
- Non-stable weight ( ±5%) within the past month.
- Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
- Known allergy to Lidocaine, Tetracaine, Xylocaine, Epinephrine or antibiotics.
- Skin disorders (skin systematic or local infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Severe solar elastosis at the intended to treat area.
- Tattoo or former tattoo at or near treatment area.
- Tendency for Melasma inflammation.
- Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising.
- Surgical or traumatic scar in the intended to treat area.
- Presence of a metal stent or implant in the facial area (e.g. braces; dental implants are not excluded).
- History of cosmetic treatments in the facial area to be treated, including blepharoplasty, direct specific forehead lift and facial skin-tightening procedure within the 6 months;injectable (Botox or fillers) of any type within the 12 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 or neck lift within the past 12 months.
- Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Aesthetic Revolution Las Vegas
Las Vegas, Nevada, 89148
Advanced dermatoloy
Lincolnshire, Illinois, 60069
New Jersey Plastic Surgeon
Montclair, New Jersey, 07042
UnionDerm
New York, New York, 10003
Premier Plastic Surgery
Palo Alto, California, 94306
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: Safety and Efficacy of Sofwave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
Open-label, non-randomized, prospective, multi-center, self-controlled
Read the detailed description
Patients will receive 2 monthly treatments with the SofWave system and will be followed up twice: at 4 weeks and 12 weeks after last treatment (FU1-FU2).
- Being tested
- Sofwave
- Keywords
- upper lip, peri-oral, philtral
- Medical subject headings
- Lymphoid Interstitial Pneumonia
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 |
|---|---|---|
| Lift the upper lip and improve the peri-oral rhytids | Experimental | Not described Receives: Device: Sofwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of improvement in the appearance of upper lip and peri-oral rhytids
Study will be considered a success if more than 50% of the subjects will have an improvement according to investigators' assessments of pre- and post Treatment 2D images
Measured: 12 weeks post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jul 2023
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidesStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofwave Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104514
- Sponsor's protocol ID
- Sofwave20
- Status last verified
- May 2025
- First submitted
- 23 Oct 2023
- Last updated
- 15 May 2025
- 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 15 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 the Upper Lip and Improve the Peri-Oral Rhytids
- ClinicalTrials.gov ID
- NCT06104514
- Acronym / sponsor ID
- Sofwave20
- Keywords
- upper lip, peri-oral, philtral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 27 Oct 2023 (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, prospective, multi-center, self-controlled
Detailed description
Patients will receive 2 monthly treatments with the SofWave system and will be followed up twice: at 4 weeks and 12 weeks after last treatment (FU1-FU2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lift the upper lip and improve the peri-oral rhytids | 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.
- Desire to improve the peri-oral appearance, decrease the distance between the nose and the upper lip (Philtral column length) and/or reduce the peri-oral rhytids.
- Philtral column height>15mm or/and has moderate severe perioral rhytids.
- Subject agrees to maintain a stable weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
Key exclusion criteria (28 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
- Melanoma active malignancy or history of malignancy in the past 5 years.
- Any other non-melanoma malignancy active malignancy or history of malignancy in the past 5 years within the intended to treat area.
- Previous chemotherapy treatments.
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 | Lift the upper lip and improve the peri-oral rhytids |
Primary outcome
Rate of improvement in the appearance of upper lip and peri-oral rhytids
Time frame: 12 weeks post last treatment
Study will be considered a success if more than 50% of the subjects will have an improvement according to investigators' assessments of pre- and post Treatment 2D images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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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.
6 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 Rhytides and Wrinkle, run by Sofwave Medical LTD at 6 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 28 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: finished, as of the sponsor's last update on 15 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 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of improvement in the appearance of upper lip and peri-oral rhytids (time frame: 12 weeks post last 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 15 May 2025.