NCT02763306

Dermal Cryotherapy in Patients Undergoing Abdominoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: R2 Dermatology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

Detailed description

This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Dermal Cooling System	Treatment with dermal cooling system.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-05-05
• Last updated: 2021-03-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study