Keloid ScarASRNCT04016610
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar
A study testing Soliton's Acoustic Scar Reduction (SAR) in people with Keloid Scar, run by Soliton at 1 site in United States.
Trial summary
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keloid Scar
- What is being tested?
- Soliton's Acoustic Scar Reduction (SAR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2019to 12 Feb 2020
- 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 older than 18 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 keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs.
- Keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm.
- Keloids less than 5 years old
- Body Mass Index (B.M.I.) is > 20
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- Participant is willing to not undergo any other keloid treatments for a period of 12 months following ASR treatment.
- Participant is willing to participate in study and adhere to follow-up schedule.
- Participant is able to read and comprehend English or Spanish.
- Participant has completed the Informed Consent Form.
Who cannot join
- Participant had treatments, including topical steroids, to the keloid 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 ASR 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, elbows, knees, etc.).
- Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clear Dermatology and Aesthetics Center
Scottsdale, Arizona, 85255
About this study
Official title: Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment Using Rapid Acoustic Pulse (RAP) Device for the Treatment of Keloid Scar
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.
Read the detailed description
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.
- Conditions
- Keloid Scar
- Being tested
- Soliton's Acoustic Scar Reduction (SAR)
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soliton's Acoustic Scar Reduction (SAR)Device
Treatment of keloid scars for the temporary improvement in appearance.
| Study group | Role | What they receive |
|---|---|---|
| ASR Treatment | Experimental | Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm. Receives: Device: Soliton's Acoustic Scar Reduction (SAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Safety
The safety endpoint will be met if all treated participants are free from unexpected adverse events and serious adverse events directly attributable to the ASR device or treatment.
Measured: 12 weeks
Secondary outcomes (1)
Treatement Tolerability
ASR treatment tolerability will be met if the average pain measure using a 0-10 pain scale across all treated Participants is < 8.0.
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 Jul 2019
- Study start9 Jul 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soliton
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Responsible party
- Sponsor
- Investigators
- Christopher Capelli, MD, Study director, Soliton, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016610
- Sponsor's protocol ID
- Soliton 2019-001
- Acronym
- ASR
- Status last verified
- Sep 2021
- First submitted
- 9 Jul 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment Using Rapid Acoustic Pulse (RAP) Device for the Treatment of Keloid Scar
- ClinicalTrials.gov ID
- NCT04016610
- Acronym / sponsor ID
- ASR / Soliton 2019-001
- Conditions
- Keloid Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SolitonIndustry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 11 Jul 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.
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.
Detailed description
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| ASR Treatment | Experimental | Device: Soliton's Acoustic Scar Reduction (SAR)Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female older than 18 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 keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs.
- Keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm.
- Keloids less than 5 years old
Key exclusion criteria (11 listed)
- Participant had treatments, including topical steroids, to the keloid 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 ASR 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, elbows, knees, etc.).
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 |
|---|---|---|
| Soliton's Acoustic Scar Reduction (SAR)Treatment of keloid scars for the temporary improvement in appearance. | Device | ASR Treatment |
Primary outcome
Procedure Safety
Time frame: 12 weeks
The safety endpoint will be met if all treated participants are free from unexpected adverse events and serious adverse events directly attributable to the ASR device or treatment.
1 secondary outcome
Treatement Tolerability
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 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Christopher Capelli, MD study director
Soliton, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soliton's Acoustic Scar Reduction (SAR) in people with Keloid Scar, 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 10 inclusion and 11 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 28 Sep 2021. 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?
Procedure Safety (time frame: 12 weeks). 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 28 Sep 2021.