Histology Evaluation of the CO2RE Device Versus the RePair Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02147756|
Recruitment Status : Unknown
Verified May 2015 by Syneron Medical.
Recruitment status was: Active, not recruiting
First Posted : May 28, 2014
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skin Pigmentation and Texture Disorders.||Device: CO2RE Device: Repair||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vivo Histology Evaluation of the CO2RE Device Versus the RePair Device in Pre- Abdominoplasty Patients|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2015|
Active Comparator: CO2RE
Fractional CO2 laser system that utilizes a sealed off, all metal carbon dioxide gas tube that is Radio Frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 μm with programmable pulse duration and frequency. The system has a programmable 2 axis scanning laser beam device that allows the physician to select the skin area coverage from a selection of predetermined patterns in different sizes based on the skin area to be treated. The versatility of the fractional CO2RE system enables precise, effective and simultaneous treatment of the skin's surface in the middle, and deep dermal levels.
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.
Other Name: Fractional CO2
Active Comparator: RePair
Fractional CO2 system that comprises an infrared laser controlled by an embedded processor and a handpiece that directs the laser treatment. The device laser has a wavelength of 10.6μm and its tissue chromophore is water. It delivers multiple low energy pulses in microscopic spots as the handpiece glides over the skin surface. The selected energy determines the depth and width for each microscopic treatment zone (MTZs).
Other Name: Fractional CO2
- Histological changes in skin tissue (epidermal, dermal and subcutaneous) of the treated areas. [ Time Frame: Immediately, 1 week or 4 weeks prior the scheduled abdominoplasty ]
The histological performance of the RePair and CO2RE devices post single treatment will be evaluated at different time points in healthy subjects scheduled for abdominoplasty procedure.
Subjects will be randomly assigned to three different time-points of laser treatment: immediately, 1 week or 4 weeks prior the scheduled abdominoplasty.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147756
|Advance Laser Therapy/Vanguardia en Terapia Laser|
|Caba, Argentina, 1001|
|Study Director:||Shlomit Mann||Syneron Medical Ltd.|