Clinical trial NCT04016610: Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar
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
Overall status: COMPLETED
Phase: NA
Conditions: Keloid Scar
Lead sponsor: Soliton
Sponsor class: INDUSTRY
Collaborators: name: Emergent Clinical Consulting, LLC
First posted: 2019-07-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Procedure Safety
timeFrame: 12 weeks
Secondary outcomes:
measure: Treatement Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology and Aesthetics Center
state: Arizona
Study officials:
affiliation: Soliton, Inc.
name: Christopher Capelli, MD
role: STUDY_DIRECTOR
References: