Clinical trial NCT02147756: Histology Evaluation of the CO2RE Device Versus the RePair Device
Official title: In Vivo Histology Evaluation of the CO2RE Device Versus the RePair Device in Pre- Abdominoplasty Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Pigmentation and Texture Disorders.
Keywords: Skin pigmentation, skin texture disorders, fractional laser, CO2, fractional CO2, Syneron, Solta.
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is scheduled and cleared for an abdominoplasty procedure by a referring plastic surgeon.
2. Subject has read and signed the informed consent form.
3. Subject is willing to follow the treatment and follow up schedule and undertake to carry out all necessary precautions and instructions.
4. Female candidates must be post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
5. Subject is willing to have photographs taken which will be used for educational and marketing presentations and/or publications.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. To verify that subjects who are enrolled are not pregnant, a urine pregnancy test will be performed for each women subject at baseline and again at the end of the study.
2. Subject has any active electrical implant anywhere in the body, such as a pacemaker, an insulin pump or an internal defibrillator.
3. Subject has a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
4. Subject is or has undergone any form of treatment for active cancer in the treated area, suffering or having a history of skin cancer or any other cancer in the treated area, including presence of malignant or pre-malignant pigmented lesions in the treated area.
5. Subject suffers from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders, hepatitis and fat metabolism disorders.
6. Subject suffers from abdominal wall hernia and is a candidate for treatment in the abdomen.
7. Subject has undergone Bariatric surgery with significant skin laxity.
8. Subject has a history of advanced fatty liver or a known liver dysfunction.
9. Subject has a thromboembolic phenomenon, hypercoagulability, and tendency to bleed or bruise or is taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion).
10. Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection) or currently using immunosuppressive medications.
11. Subject has a history of significant lymphatic drainage problems.
12. Subject is suffering from hormonal imbalance which may affect weight, as per the Investigator's discretion.
13. Subject is suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
14. Subject has a history of epidermal or dermal disorders (particularly if involving collagen or microvascularity), keloid scarring or of abnormal wound healing.
15. Subject received treatment with laser or other devices in the treated areas within 6 months of treatment.
16. Subject underwent a liposuction surgery or any contouring treatment in the areas intended for treatment within 9 months of treatment.
17. Subject is recently tanned in areas to be treated.
18. Subject is participating in a study of another device or drug within 1 month prior to enrollment or during this study.
19. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Primary outcomes:
measure: Histological changes in skin tissue (epidermal, dermal and subcutaneous) of the treated areas.
timeFrame: Immediately, 1 week or 4 weeks prior the scheduled abdominoplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Advance Laser Therapy/Vanguardia en Terapia Laser
Study officials:
affiliation: Syneron Medical Ltd.
name: Shlomit Mann
role: STUDY_DIRECTOR
References: