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Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar (ASR)

Primary Purpose

Keloid Scar

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soliton's Acoustic Scar Reduction (SAR)
Sponsored by
Soliton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Keloid Scar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clear Dermatology and Aesthetics Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASR Treatment

Arm Description

Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 9, 2019
Last Updated
September 22, 2021
Sponsor
Soliton
Collaborators
Emergent Clinical Consulting, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04016610
Brief Title
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar
Acronym
ASR
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soliton
Collaborators
Emergent Clinical Consulting, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid Scar

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASR Treatment
Arm Type
Experimental
Arm Description
Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm.
Intervention Type
Device
Intervention Name(s)
Soliton's Acoustic Scar Reduction (SAR)
Intervention Description
Treatment of keloid scars for the temporary improvement in appearance.
Primary Outcome Measure Information:
Title
Procedure Safety
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Treatement Tolerability
Description
ASR treatment tolerability will be met if the average pain measure using a 0-10 pain scale across all treated Participants is < 8.0.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Capelli, MD
Organizational Affiliation
Soliton, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clear Dermatology and Aesthetics Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar

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