Scars, HypertrophicNCT04702529
Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device
A study testing Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device) in people with Scars, Hypertrophic, run by Soliton at 1 site in United States.
Trial summary
A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars, Hypertrophic
- What is being tested?
- Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older at the screening visit.
- The participant is healthy, as determined by the investigator based on a medical evaluation including medical history.
- The participant has a fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs.
- Scar must be located an essentially planar surface.
- Scar size preferably between 2.5 cm2 and 5 cm2.
- Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm.
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- Scar less than 5 years old.
- Participant is willing to forego any other scar treatments until complete with study participation.
- Participant is willing to participate in study and adhere to follow-up schedule.
- Participant is able to read and comprehend English.
- Regardless of the above, the final decision on scar inclusion will rest with the PI.
Who cannot join
- Participant is sensitive to loud sounds
- Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months.
- Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
- Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
- Participant is pregnant or planning to become pregnant during the duration of the study.
- Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, etc.).
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- Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
- Medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.).
- History of coagulopathy(ies) and/or on anticoagulant medication.
- Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Current smoker.
- Any surgical procedure in the prior 3 months, or planned during the duration of the study.
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the participant's ability to fulfill study obligations
- Treatment with another investigational device or agent within 30 days before treatment or during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Naval Medical Center
San Diego, California, 92134
About this study
Official title: Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study
A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars
Read the detailed description
Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'
- Conditions
- Scars, Hypertrophic
- Being tested
- Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)Device
Administration of 3 Rapid Acoustic Pulse (RAP) treatments
| Study group | Role | What they receive |
|---|---|---|
| Three treatments to hypertrophic scar with RAP device | Experimental | RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments Receives: Device: Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
Measured: Immediately post treatment
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)Procedure Safety
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
Measured: up to 14 days
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be evaluated before each treatment which occurs every 2 weeks, (+/- 1 week) and will be reported
Measured: up to 3 week post treatment
Change from baseline scar Global Aesthetic Improvement Scale at 12 weeks
Noted improvement in scar appearance via Global Aesthetic Improvement Scale
Scale (GAIS) as reported by the Principal Investigator (PI). Minimum value 1 and maximum value 5, with higher score meaning worse outcome.
Measured: 12 weeks
Secondary outcomes (2)
Change in baseline scar Global Aesthetic Improvement scale at 12 weeks
Noted improvement in scar via Patient and Observer Scar Assessment Scale (POSAS). Minimum value 1 and maximum value 10, with higher scores meaning a better outcome.
Measured: 12 weeks
Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks
Noted improvement in scar appearance via Global Aesthetic Improvement Scale (GAIS) as reported by the participant. Minimum value 1 and maximum value 5, with higher score meaning worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start22 Jun 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scars, 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soliton
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702529
- Sponsor's protocol ID
- 2021-01
- Status last verified
- May 2023
- First submitted
- 4 Jan 2021
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT04702529
- Acronym / sponsor ID
- 2021-01
- Conditions
- Scars, Hypertrophic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SolitonIndustry (pharma, biotech, devices)
- Collaborators
- United States Naval Medical Center, San Diego
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Jan 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.
A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars
Detailed description
Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three treatments to hypertrophic scar with RAP device | Experimental | Device: Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female 18 years of age or older at the screening visit.
- The participant is healthy, as determined by the investigator based on a medical evaluation including medical history.
- The participant has a fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs.
- Scar must be located an essentially planar surface.
- Scar size preferably between 2.5 cm2 and 5 cm2.
Key exclusion criteria (14 listed)
- Participant is sensitive to loud sounds
- Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months.
- Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
- Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
- Participant is pregnant or planning to become pregnant during the duration of the study.
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 |
|---|---|---|
| Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)Administration of 3 Rapid Acoustic Pulse (RAP) treatments | Device | Three treatments to hypertrophic scar with RAP device |
Primary outcome
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Time frame: Immediately post treatment
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)Procedure Safety
Time frame: up to 14 days
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Time frame: up to 3 week post treatment
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be evaluated before each treatment which occurs every 2 weeks, (+/- 1 week) and will be reported
Change from baseline scar Global Aesthetic Improvement Scale at 12 weeks
Time frame: 12 weeks
Noted improvement in scar appearance via Global Aesthetic Improvement Scale Scale (GAIS) as reported by the Principal Investigator (PI). Minimum value 1 and maximum value 5, with higher score meaning worse outcome.
2 secondary outcomes
Change in baseline scar Global Aesthetic Improvement scale at 12 weeks
Time frame: 12 weeks
Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks
Time frame: 12 weeks
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 24 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device) in people with Scars, Hypertrophic, run by Soliton 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 11 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 24 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?
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?
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs) (time frame: Immediately post treatment). The study lists 4 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 24 Dec 2024.