Status:
COMPLETED
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar
Lead Sponsor:
Soliton
Collaborating Sponsors:
Emergent Clinical Consulting, LLC
Conditions:
Keloid Scar
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04016610
Start Date
July 9 2019
End Date
February 12 2020
Last Update
September 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clear Dermatology and Aesthetics Center
Scottsdale, Arizona, United States, 85255