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

NCT04016610 | Completed FDA Device

• 1 other identifier: Soliton 2019-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.

Conditions

Keloid Scar

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Treatement Tolerability

  12 weeks

Study Arms (1)

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.

Device: Soliton's Acoustic Scar Reduction (SAR)

Interventions

Soliton's Acoustic Scar Reduction (SAR) DEVICE

Treatment of keloid scars for the temporary improvement in appearance.

ASR Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soliton: lead
• Emergent Clinical Consulting, LLC: collaborator

Study Sites (1)

Clear Dermatology and Aesthetics Center

Scottsdale, Arizona, 85255, United States

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Capelli, MD

  Soliton, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: July 9, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)