NCT02147756

Histology Evaluation of the CO2RE Device Versus the RePair Device

In Vivo Histology Evaluation of the CO2RE Device Versus the RePair Device in Pre- Abdominoplasty Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare structural changes in the skin caused by the CO2RE device versus the Repair.

Detailed description

The CO2RE is a fractional CO2 system that enables, precise, effective and simultaneous treatment of the skin's surface, middle, and deep dermal levels then seamlessly performing traditional CO2 resurfacing and laser excision of lesions with precision-control over the intensity, pattern, and depth of ablation. RePair is a 10,600nm fractional CO2 laser system that targets aging and sun-damaged skin with microscopic laser columns that penetrate deep into the skin to expedite the body's remodeling of collagen.

Conditions

• Skin Pigmentation and Texture Disorders.

Interventions

Type	Name	Description
DEVICE	CO2RE	Subjects will be randomly assigned to three different time-points of laser treatment: immediately, 1 week or 4 weeks prior the scheduled abdominoplasty. Subjects will be required to attend between 2 to 3 visits depending on the interval between the treatment and the abdominoplasty procedure. One side of the abdomen will be treated using the CO2RE device and the other side with the RePair device. The investigator will also leave an untreated area (control). Punch biopsies will be obtained before or during the abdominoplasty procedure from the two treated areas (CO2RE and RePair) and one control (un-treated) areas (on the abdominoplasty area) for histological evaluation.
DEVICE	Repair

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• First posted: 2014-05-28
• Last updated: 2015-05-27

Locations

1 site across 1 country: Argentina