Lax SkinNCT05358327
Treatment for Lifting Upper Arm Lax Skin
A study testing Sofwave in people with Lax Skin, run by Sofwave Medical LTD at 4 sites in United States.
Trial summary
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation. Read more about this study
- Who is it for?
- Ages 35 to 70 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
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2022to 1 Feb 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 35 years of age and < 70 years of age.
- Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
- Desire to undergo upper arms skin lax lifting treatments.
- Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
- Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
- Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
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- Willing to have research photos taken of treatment areas.
- Subject agrees not to undergo any other upper arm skin lax treatments for a period of 3 months following Sofwave treatment.
- Able to understand and provide written Informed Consent.
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.).
- History of Epileptic seizures.
- Known allergy to lidocaine or epinephrine or antibiotics.
- Active malignancy or history of malignancy in the past 5 years.
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- 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).
- 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.
- Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
- History of chronic drug or alcohol abuse.
- History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Currently taking or has taken diet pills or weight control supplements within the past month.
- BMI>=30kg/m2
- Non-stable weight nominally ±5% for at the past month.
- Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.).
- History of prior surgery in the upper arms.
- Excessive subcutaneous fat on the upper arms.
- Severe solar elastosis on the intended to treat area.
- Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising.
- Tattoo or former tattoo at or near treatment area.
- Presence of an implant in or adjacent to area of intended treatment (upper arms).
- History of ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peeling within the past 12 months on the intended to treat area.
- Inability to understand the protocol or to give informed consent.
- On-going use of psychiatric medication.
- Unable or unwilling to comply with the study requirements and procedures.
- Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003
Advanced Dermatology
Lincolnshire, Illinois, 60069
Laser & Skin Surgery Center of New York®
New York, New York, 10016
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Official title: Safety and Efficacy of Sofwave Treatment to Lift Upper Arm Lax Skin
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Read the detailed description
Eligible patients will receive 2 treatments on both upper arms (4-6 weeks apart) using the Sofwave System.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for 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
- upper arms, lax skin
- Medical subject headings
- Cutis Laxa, Rhabdomyosarcoma, Alveolar
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 |
|---|---|---|
| Upper Arm | 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 of upper arms lax skin
following Sofwave treatment as evaluated by independent masked reviewers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 May 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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
- 50 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, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358327
- Sponsor's protocol ID
- Sofwave07
- Status last verified
- Mar 2022
- First submitted
- 19 Apr 2022
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sofwave Treatment to Lift Upper Arm Lax Skin
- ClinicalTrials.gov ID
- NCT05358327
- Acronym / sponsor ID
- Sofwave07
- Conditions
- Lax Skin
- Keywords
- upper arms, lax skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 3 May 2022 (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 clinical study with masked evaluation.
Detailed description
Eligible patients will receive 2 treatments on both upper arms (4-6 weeks apart) using the Sofwave System.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for 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 |
|---|---|---|
| Upper Arm | Experimental | Device: Sofwave |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects > 35 years of age and < 70 years of age.
- Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
- Desire to undergo upper arms skin lax lifting treatments.
- Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
- Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
Key exclusion criteria (31 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.).
- History of Epileptic seizures.
- Known allergy to lidocaine or epinephrine or antibiotics.
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 | Upper Arm |
Primary outcome
Rate of improvement of upper arms lax skin
Time frame: 1 year
following Sofwave treatment as evaluated by independent masked reviewers
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 18 Nov 2023.
- 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.
Ruthie Amir, MD study director
CMO
4 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 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 9 inclusion and 31 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 18 Nov 2023. 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.
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 of upper arms lax skin (time frame: 1 year). 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 18 Nov 2023.