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

NCT ID: NCT04016610

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2020-02-12

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.

Conditions

Keloid Scar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

ASR Treatment

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

Group Type: EXPERIMENTAL

Soliton's Acoustic Scar Reduction (SAR)

Intervention Type: DEVICE

Treatment of keloid scars for the temporary improvement in appearance.

Interventions

Soliton's Acoustic Scar Reduction (SAR)

Treatment of keloid scars for the temporary improvement in appearance.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent Clinical Consulting, LLC

INDUSTRY

Sponsor Role: collaborator

Soliton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Capelli, MD

Role: STUDY_DIRECTOR

Soliton, Inc.

Locations

Clear Dermatology and Aesthetics Center

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

Soliton 2019-001

Identifier Type: -

Identifier Source: org_study_id