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

Scars, Hypertrophic Clinical Trial

Official title:

Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04702529
• Other study ID #: 2021-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2022
• Source: Soliton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female 18 years of age or older at the screening visit.

2. The participant is healthy, as determined by the investigator based on a medical evaluation including medical history.

3. 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.

4. Scar must be located an essentially planar surface.

5. Scar size preferably between 2.5 cm2 and 5 cm2.

6. Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm.

7. Scar less than 5 years old.

8. Participant is willing to forego any other scar treatments until complete with study participation.

9. Participant is willing to participate in study and adhere to follow-up schedule.

10. Participant is able to read and comprehend English.

Regardless of the above, the final decision on scar inclusion will rest with the PI.

Exclusion Criteria:

1. Participant is sensitive to loud sounds

2. Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months.

3. Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.

4. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.

5. Participant is pregnant or planning to become pregnant during the duration of the study.

6. Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, etc.).

7. Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.

8. Medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.).

9. History of coagulopathy(ies) and/or on anticoagulant medication.

10. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.

11. Current smoker.

12. Any surgical procedure in the prior 3 months, or planned during the duration of the study.

13. 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

14. Treatment with another investigational device or agent within 30 days before treatment or during the study period

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Scars, Hypertrophic

Intervention

Device:
• Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)
Administration of 3 Rapid Acoustic Pulse (RAP) treatments

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Soliton	United States Naval Medical Center, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in baseline scar Global Aesthetic Improvement scale at 12 weeks	Noted improvement in scar via Patient and Observer Scar Assessment Scale (POSAS). Minimum value 1 and maximum value 10, with higher scores meaning a better outcome.	12 weeks
Secondary	Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks	Noted improvement in scar appearance via Global Aesthetic Improvement Scale (GAIS) as reported by the participant. Minimum value 1 and maximum value 5, with higher score meaning worse outcome.	12 weeks