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

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

    • 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

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

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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