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

Keloid Scar Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016610
• Other study ID #: Soliton 2019-001
• Status: Completed
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: September 2021
• Source: Soliton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keloid
• Keloid Scar

Intervention

Device:
• Soliton's Acoustic Scar Reduction (SAR)
Treatment of keloid scars for the temporary improvement in appearance.

Locations

Country	Name	City	State
United States	Clear Dermatology and Aesthetics Center	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Soliton	Emergent Clinical Consulting, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks