- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016610
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar (ASR)
September 22, 2021 updated by: Soliton
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
-
Scottsdale, Arizona, United States, 85255
- Clear Dermatology and Aesthetics Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ASR Treatment
Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm.
|
Treatment of keloid scars for the temporary improvement in appearance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatement Tolerability
Time Frame: 12 weeks
|
ASR treatment tolerability will be met if the average pain measure using a 0-10 pain scale across all treated Participants is < 8.0.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Christopher Capelli, MD, Soliton, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 9, 2019
Primary Completion (ACTUAL)
February 12, 2020
Study Completion (ACTUAL)
February 12, 2020
Study Registration Dates
First Submitted
July 9, 2019
First Submitted That Met QC Criteria
July 9, 2019
First Posted (ACTUAL)
July 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soliton 2019-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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