Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device

NCT04702529 | Completed

• 1 other identifier: 2021-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars

Conditions

Scars, Hypertrophic

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)

  Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported

  Immediately post treatment

• Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)Procedure Safety

  Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported

  up to 14 days

• Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)

  Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be evaluated before each treatment which occurs every 2 weeks, (+/- 1 week) and will be reported

  up to 3 week post treatment

• Change from baseline scar Global Aesthetic Improvement Scale at 12 weeks

  Noted improvement in scar appearance via Global Aesthetic Improvement Scale Scale (GAIS) as reported by the Principal Investigator (PI). Minimum value 1 and maximum value 5, with higher score meaning worse outcome.

  12 weeks

Secondary Outcomes (2)

• Change in baseline scar Global Aesthetic Improvement scale at 12 weeks

  12 weeks

• Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks

  12 weeks

Study Arms (1)

Three treatments to hypertrophic scar with RAP device

EXPERIMENTAL

RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments

Device: Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)

Interventions

Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device) DEVICE

Administration of 3 Rapid Acoustic Pulse (RAP) treatments

Three treatments to hypertrophic scar with RAP device

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 18 years of age or older 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 fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs.
• Scar must be located an essentially planar surface.
• Scar size preferably between 2.5 cm2 and 5 cm2.
• Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm.
• Scar less than 5 years old.
• Participant is willing to forego any other scar treatments until complete with study participation.
• Participant is willing to participate in study and adhere to follow-up schedule.
• Participant is able to read and comprehend English.

You may not qualify if:

• Participant is sensitive to loud sounds
• Participant had treatments, including topical steroids, to the scar 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 RAP 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, knees, elbows, 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.
• Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the participant's ability to fulfill study obligations
• Treatment with another investigational device or agent within 30 days before treatment or during the study period

Sponsors & Collaborators

• Soliton: lead
• United States Naval Medical Center, San Diego: collaborator

Study Sites (1)

San Diego Naval Medical Center

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 11, 2021
• Study Start: June 22, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 24, 2024

Record last verified: 2023-05

Locations

US (1)