Skin LaxityPhase 3NCT04829227
Safety and Efficacy of Sofwave Treatment to Lift Lax Skin
A Phase 3 study testing Sofwave in people with Skin Laxity, run by Sofwave Medical LTD at 4 sites in United States.
Trial summary
Open-label, non-randomized 2 arms 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
- 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
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Jan 2020to 31 Dec 2021
- Phase
- Phase 3
- 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.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift lax skin in the neck and submental and/or to lift the brows.
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
- 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.
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.
- History of smoking in 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, acutance uses 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 give informed consent.
- History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months ; injectable (Botox or fillers) of any type within the 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
4 sites in 1 country.
United States4 sites
SLSS, a Division of Schweiger Dermatology Group Research Office
Hackensack, New Jersey, 07601
The Practice of Brian S. Biesman, MD
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
McDaniel Institute of Aging Research
Virginia Beach, Virginia, 23462
About this study
Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.
Read the detailed description
This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. 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 visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.
- Conditions
- Skin Laxity
- Being tested
- Sofwave
- Keywords
- Laxity Brow Lifting Skin Saggy
- 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 |
|---|---|---|
| face and/or neck and/or submental zones | Experimental | the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck Receives: Device: Sofwave |
| "off the face" areas | Experimental | "off the face" areas: abdomen, or arms or thighs or Décolleté. Receives: Device: Sofwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in lifting of lax tissue
as assessed by independent masked evaluators of pre and post treatment images.
Measured: 3 and 6 months 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 posted2 Apr 2021
- Study start10 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofwave Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruthie Amir, MD, Study director, Sofwave
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829227
- Sponsor's protocol ID
- Sofwave05
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 26 Oct 2022
- 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 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sofwave Treatment to Lift Lax Skin
- ClinicalTrials.gov ID
- NCT04829227
- Acronym / sponsor ID
- Sofwave05
- Conditions
- Skin Laxity
- Keywords
- Laxity Brow Lifting Skin Saggy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Apr 2021 (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 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.
Detailed description
This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. 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 visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face and/or neck and/or submental zones | Experimental | Device: Sofwavethe full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck |
| "off the face" areas | Experimental | Device: Sofwave"off the face" areas: abdomen, or arms or thighs or Décolleté. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy female and male subjects between the ages 35-80.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift lax skin in the neck and submental and/or to lift the brows.
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
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.
- History of smoking in 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. | Device | "off the face" areas, face and/or neck and/or submental zones |
Primary outcome
Improvements in lifting of lax tissue
Time frame: 3 and 6 months post last treatment
as assessed by independent masked evaluators of pre and post treatment 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 26 Oct 2022.
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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.
Ruthie Amir, MD study director
Sofwave
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofwave in people with Skin Laxity, run by Sofwave Medical LTD at 4 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 7 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: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvements in lifting of lax tissue (time frame: 3 and 6 months 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 26 Oct 2022.