NCT05102617

Post Market Usability Evaluation Of The PicoSure Pro Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intended use of the PicoSure and PicoSure Pro devices used in this study is to treat additional patients with the new PicoSure Pro device and collect additional data on the devices.

Detailed description

Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 100 subjects will be enrolled at up to 4 study centers. Subjects will be enrolled into one of the 3 groups; Group A, Group B, or Group C.

Conditions

• Wrinkle
• Acne Scars
• Benign Epidermal Pigmented Lesions
• Benign Dermal Pigmented Lesions
• Tattoo Removal

Interventions

Type	Name	Description
DEVICE	PicoSure Pro Device	This device will be used for up to 4 treatments over the designated areas.
DEVICE	PicoSure Device	This device will be used for up to 4 treatments over the designated areas.
DRUG	Topical Cosmeceuticals	Topical cosmeceuticals, such as a hydrating serum or cream, will be applied on the designated area.

Timeline

• Start date: 2021-10-21
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2021-11-01
• Last updated: 2024-01-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study