NCT05358860

Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Detailed description

Eligible patients will receive 3 treatments (4-6 weeks apart) on the facial acne scars using Sofwave System. Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visit at 3 months ± 3 weeks post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Conditions

• Acne Scars - Mixed Atrophic and Hypertrophic

Interventions

Type	Name	Description
DEVICE	Sofwave	The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-05-03
• Last updated: 2023-11-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study