NCT04493021

Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: R2 Dermatology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.

Detailed description

This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to reduce pigmentation in benign pigmented lesions and to determine if additional cosmetic benefits are achieved.

Conditions

• Pigmentation

Interventions

Type	Name	Description
DEVICE	Dermal Cooling System	Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System

Timeline

• Start date: 2020-07-07
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-07-30
• Last updated: 2023-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study