NCT05579171

Lasers to Aid in Treatment of Acne Scars

A Single Center, Evaluator-Blinded, Split-Face, Randomized Clinical Trial of Combination Treatment With Fractional Picosecond 755nm Alexandrite Laser and Radiofrequency Microneedling for Atrophic Acne Scars

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess efficacy and safety of paired picosecond 755nm Alexandrite laser with focused lens array (PSAL; Picosure®, Cynosure, Westford, MA) and radiofrequency microneedling (RFM; Potenza™, Cynosure, Westford, MA) for treatment of facial, atrophic acne scars.

Detailed description

The primary objective of this clinical trial is to assess efficacy and safety of combination treatment with fractional picosecond 755nm Alexandrite laser with focused lens array (Picosure®, Cynosure, Westford, MA) and radiofrequency microneedling (Potenza™, Cynosure, Westford, MA) for treatment of facial, atrophic acne scarring. Enrolled subjects will be randomized to receive picosecond 755 nm Alexandrite laser treatment to either the left or right facial half. The subjects will then undergo full face radiofrequency microneedling (RFM). Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photographs will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.

Conditions

• Acne Scars

Interventions

Type	Name	Description
DEVICE	Picosecond 755nm Alexandrite Laser	Fractionated picosecond technology has been shown to lead to statistically significant improvement in atrophic, facial acne scars after 4-6 treatment sessions with minimal pain or downtime
DEVICE	Picosecond 755nm Alexandrite Laser	Fractionated picosecond technology has been shown to lead to statistically significant improvement in atrophic, facial acne scars after 4-6 treatment sessions with minimal pain or downtime

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2022-10-13
• Last updated: 2022-10-13

Regulatory

• FDA-regulated device study