Acne Scars - Mixed Atrophic and HypertrophicNCT05358860
Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement
A study testing Sofwave in people with Acne Scars - Mixed Atrophic and Hypertrophic, 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 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic
- 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
- 4 sitesUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2022
- 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 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects > 22 years of age and < 80 years of age.
- For female subjects, 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.
- Seeking treatment for facial acne scars.
- Have visible mild to moderate facial acne scars.
- Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.
- Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
- Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
- Able to understand and provide written Informed Consent
Who cannot join
- Pregnant or planning to become pregnant during the duration of the study, 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.
- History of severe migraine tendency.
- History of Epileptic seizures.
- History of chronic drug or alcohol abuse.
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
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- Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
- Presence of a metal stent or implant in the facial area.
- Known allergy to tetracaine, Xylocaine or epinephrine.
- Active malignancy or history of malignancy in the past 5 years.
- 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.
- Presence of any active systemic or local infections.
- Severe or cystic facial acne, acutance uses during past 6 months.
- 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 or blepharoplasty within the past 12 months.
- 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
- 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
UnionDerm
New York, New York, 10003
Laser & Skin Surgery Center of New York®
New York, New York, 10016
New York Laser & Skin Care
New York, New York, 10028
About this study
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Read the detailed description
Eligible patients will receive 3 treatments (4-6 weeks apart) on the facial acne scars using 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 one follow up visit at 3 months ± 3 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.
- Being tested
- Sofwave
- Keywords
- Acne Scars
- Medical subject headings
- Hypertrophy
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 |
|---|---|---|
| Acne Scars | 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 change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.
following Sofwave treatments based on 6 points simplified Acne Severity Scale (ASS), 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 Feb 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies 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
- NCT05358860
- Sponsor's protocol ID
- Sofwave09
- Status last verified
- Apr 2023
- First submitted
- 27 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 for Acne Scars Appearance Improvement
- ClinicalTrials.gov ID
- NCT05358860
- Acronym / sponsor ID
- Sofwave09
- Keywords
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (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 3 treatments (4-6 weeks apart) on the facial acne scars using 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 one follow up visit at 3 months ± 3 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 |
|---|---|---|
| Acne Scars | Experimental | Device: Sofwave |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male or female subjects > 22 years of age and < 80 years of age.
- For female subjects, 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.
- Seeking treatment for facial acne scars.
- Have visible mild to moderate facial acne scars.
- Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.
Key exclusion criteria (20 listed)
- Pregnant or planning to become pregnant during the duration of the study, 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.
- History of severe migraine tendency.
- History of Epileptic seizures.
- History of chronic drug or alcohol abuse.
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 | Acne Scars |
Primary outcome
Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.
Time frame: 1 year
following Sofwave treatments based on 6 points simplified Acne Severity Scale (ASS), 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acne Scars - Mixed Atrophic and Hypertrophic, 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 8 inclusion and 20 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 change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session. (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.