NCT04807179

Clinical Study to Evaluate Alexandrite Laser for the Treatment of Acne Scars

Prospective Clinical Study To Evaluate The Efficacy And Safety Of An Alexandrite Laser Device For The Treatment Of Acne Scars

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI.

Detailed description

Subjects are to be enrolled in this clinical study if they are 18-65 years old. A maximum of 25 subjects will be enrolled at 1 study center. Subjects will receive up to 6 treatments (minimum of 4 treatment visits with an optional 5th and 6th treatment) on the face. Subjects will return for follow up visits at 30 and 90 days post last treatment. All subjects will receive a phone call 1 week after each treatment.

Conditions

• Acne Scars

Interventions

Type	Name	Description
DEVICE	Experimental: RF Device Arm	Non-invasive radiofrequency Alexandrite laser

Timeline

• Start date: 2021-03-08
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2021-03-19
• Last updated: 2024-05-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study