Skin Lax and Muscle StrengthNCT06724146
Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance
A study testing Sofwave and Pure Impact in people with Skin Lax and Muscle Strength, run by Sofwave Medical LTD at 1 site in United States.
Trial summary
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Lax and Muscle Strength
- What is being tested?
- Sofwave and Pure Impact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 1 Nov 2026
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 25 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 treatments on upper arms for skin lax and for strength and tone muscles.
- 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 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 and Pure Impact treatments.
- 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, open wounds etc.) in the treatment area.
- Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
- Known allergy to lidocaine or epinephrine.
- Active malignancy or history of malignancy in the past 5 years.
- Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (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 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 a 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.
- BMI>30kg/m2
- Non-stable weight nominally ±5% in the past month.
- Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.
- Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
- 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.
- Muscle atrophy.
- Need for muscle rehabilitation.
- Persistent pain at the treated area.
- Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).
- 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.
- 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
1 site in 1 country.
United States1 site
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: Safety and Efficacy of Upper Arm Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study.
Read the detailed description
Eligible patients will receive combined treatment on both upper arms, included 1 or 2 SofWave treatments and 4 Pure Impact treatments. At the first session (Visit 1), subjects undergo SofWave treatment, and may undergo Pure Impact treatment also at the same visit. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the Pure Impact 2-7 days after the SofWave procedure. If the two treatments are conducted on the same day, then the second Pure Impact session will be 7-10 days after; similarly, the third and fourth Pure Impact sessions will be performed 7-10 days apart following the previous session. The last (fourth) Pure Impact treatment may occur on the same day or after the optional second SofWave treatment. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the SofWave 2-7 days after the fourth Pure Impact procedure.
All patients will return to the clinic for two follow-up visits at 4±1 weeks and at 12±2 weeks post last treatment (FU1 and FU2).
- Conditions
- Skin Lax and Muscle Strength
- Being tested
- Sofwave and Pure Impact
- Keywords
- Upper arm, skin laxity, muscle tone, muscle strength, muscle firm
- 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 and Pure ImpactDevice
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.
Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Lax Tissue and Muscles | Experimental | Not described Receives: Device: Sofwave and Pure Impact |
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 and in the strength and tone muscles in the upper arms following Sofwave and Pure Impact combined treatment 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 posted9 Dec 2024
- Study start5 Aug 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Lax and Muscle StrengthStudies 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
- 70 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
- NCT06724146
- Sponsor's protocol ID
- Sofwave25
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Upper Arm Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance
- ClinicalTrials.gov ID
- NCT06724146
- Acronym / sponsor ID
- Sofwave25
- Conditions
- Skin Lax and Muscle Strength
- Keywords
- Upper arm, skin laxity, muscle tone, muscle strength, muscle firm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Dec 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, prospective, multi-center, self-controlled clinical study.
Detailed description
Eligible patients will receive combined treatment on both upper arms, included 1 or 2 SofWave treatments and 4 Pure Impact treatments. At the first session (Visit 1), subjects undergo SofWave treatment, and may undergo Pure Impact treatment also at the same visit. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the Pure Impact 2-7 days after the SofWave procedure. If the two treatments are conducted on the same day, then the second Pure Impact session will be 7-10 days after; similarly, the third and fourth Pure Impact sessions will be performed 7-10 days apart following the previous session. The last (fourth) Pure Impact treatment may occur on the same day or after the optional second SofWave treatment. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the SofWave 2-7 days after the fourth Pure Impact procedure.
All patients will return to the clinic for two follow-up visits at 4±1 weeks and at 12±2 weeks post last treatment (FU1 and FU2).
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 and Muscles | Experimental | Device: Sofwave and Pure Impact |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects ≥ 25 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 treatments on upper arms for skin lax and for strength and tone muscles.
- 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 study.
Key exclusion criteria (32 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, open wounds etc.) in the treatment area.
- Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
- Known allergy to lidocaine or epinephrine.
- Active malignancy or history of malignancy in the past 5 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 |
|---|---|---|
| Sofwave and Pure ImpactAlso: SUPERBThe Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. | Device | Lax Tissue and Muscles |
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 and in the strength and tone muscles in the upper arms following Sofwave and Pure Impact combined treatment 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 9 Dec 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sofwave and Pure Impact in people with Skin Lax and Muscle Strength, run by Sofwave Medical LTD at 1 site 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 32 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
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 9 Dec 2024.