Skin LaxityPhase 2NCT04146584
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
A Phase 2 study testing Sofwave Treatments in people with Skin Laxity and Wrinkle, run by Sofwave Medical LTD at 5 sites in United States.
Trial summary
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow. 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, Wrinkle, Brow Lifting
- What is being tested?
- Sofwave Treatments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2019to 30 Mar 2021
- Phase
- Phase 2
- 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 Epileptic seizures.
- History of severe migraine tendency.
Show all 18Show fewer
- History of smoking in past 10 years.
- History of chronic drug or alcohol abuse.
- 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.
- Inability to understand the protocol or to give informed consent.
- On-going use of psychiatric medication.
- History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face 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 psychiatric drugs, 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Dermatology & Laser Surgery Center
Houston, Texas, 77030
Laser & Skin Surgery Center of New York®
New York, New York, 10016
New York Laser & Skin Care
New York, New York, 10028
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Read the detailed description
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).
- Conditions
- Skin Laxity, Wrinkle, Brow Lifting
- Being tested
- Sofwave Treatments
- Keywords
- Skin Laxity, Submental, Neck, Brow Lifting, Laxity, 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.
Sofwave TreatmentsDevice
The device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck.
| Study group | Role | What they receive |
|---|---|---|
| Sofwave Treatment | Experimental | In this arm (single) patients would be treated twice with Sofwave on the face and/or submental and neck. Receives: Device: Sofwave Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck \& Submental) would be ranked individually. The primary endpoint would only be achieved along with success in outcome #5.
Measured: 3 months post last treatment follow up visit
Safety Investigator Assessments
Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician. The investigator would examine the patient's skin before and after treatments and on follow up visits and would be requested to fill in a physician assessment, ranking Edema, erythema, ulceration/erosion, hypopigmentation and hyperpigmentation on a 5 option scale ranging from 0. - Absent to 4. Prominent. Safety would be checked every visit.
Measured: 3 months post last treatment follow up visit
Secondary outcomes (2)
Efficacy Investigator Assessments
Evaluate investigator assessment of clinical improvement in the treated zones using the Physician Global Aesthetic Improvement Scale (PGAIS). In this scale the treating physician would have to select the proper answer regarding treatment efficacy out of 5 options ranging from: 1. Very Much Improved to 5. Worse. Each treated zone (Eyebrows, Neck \& Submental) would be ranked individually.
Measured: On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
Subject Efficacy Assessments
Evaluate patient assessment of clinical improvement in the treated zones and treatment satisfaction using the patient satisfaction questionnaire. The patient would be given a patient satisfaction questionnaire with three questions regarding overall improvement (scale of 5 options ranging from 0. Worse to 4. Very much improved ), overall satisfaction (scale of 5 options ranging from 0. Very Satisfied to 4. Very Unsatisfied) and a question regarding willing to participate in future studies (options of Yes, No, Not sure). Each treated zone (Eyebrows, Neck \& Submental) would be ranked individually.
Measured: On the second treatment visit date (pre treatment), 3 months post last 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 posted31 Oct 2019
- Study start20 Nov 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofwave Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avishai Tzur, Study chair, Clinical Projects Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146584
- Sponsor's protocol ID
- Sofwave04
- Status last verified
- Jul 2021
- First submitted
- 25 Oct 2019
- Last updated
- 22 Jul 2021
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
- ClinicalTrials.gov ID
- NCT04146584
- Acronym / sponsor ID
- Sofwave04
- Conditions
- Skin Laxity, Wrinkle, Brow Lifting
- Keywords
- Skin Laxity, Submental, Neck, Brow Lifting, Laxity, Saggy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 31 Oct 2019 (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.
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Detailed description
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofwave Treatment | Experimental | Device: Sofwave TreatmentsIn this arm (single) patients would be treated twice with Sofwave on the face and/or submental and neck. |
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 (18 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 Epileptic seizures.
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 |
|---|---|---|
| Sofwave TreatmentsThe device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck. | Device | Sofwave Treatment |
Primary outcome
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
Time frame: 3 months post last treatment follow up visit
Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck \& Submental) would be ranked individually. The primary endpoint would only be achieved along with success in outcome #5.
Safety Investigator Assessments
Time frame: 3 months post last treatment follow up visit
Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician. The investigator would examine the patient's skin before and after treatments and on follow up visits and would be requested to fill in a physician assessment, ranking Edema, erythema, ulceration/erosion, hypopigmentation and hyperpigmentation on a 5 option scale ranging from 0. - Absent to 4. Prominent. Safety would be checked every visit.
2 secondary outcomes
Efficacy Investigator Assessments
Time frame: On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
Subject Efficacy Assessments
Time frame: On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
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 22 Jul 2021.
- 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.
Avishai Tzur study chair
Clinical Projects Manager
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sofwave Treatments in people with Skin Laxity and Wrinkle, run by Sofwave Medical LTD at 5 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 18 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators (time frame: 3 months post last 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 22 Jul 2021.