Skin Pigmentation and Texture Disorders. Clinical Trial
Official title:
In Vivo Histology Evaluation of the CO2RE Device Versus the RePair Device in Pre- Abdominoplasty Patients
| NCT number | NCT02147756 |
| Other study ID # | DHF12531 |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | N/A |
| First received | May 22, 2014 |
| Last updated | May 26, 2015 |
| Start date | May 2014 |
| Verified date | May 2015 |
| Source | Syneron Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to compare structural changes in the skin caused by the CO2RE device versus the Repair.
| Status | Active, not recruiting |
| Enrollment | 2 |
| Est. completion date | |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Advance Laser Therapy/Vanguardia en Terapia Laser | Caba |
| Lead Sponsor | Collaborator |
|---|---|
| Syneron Medical |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Histological changes in skin tissue (epidermal, dermal and subcutaneous) of the treated areas. | 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. |
Immediately, 1 week or 4 weeks prior the scheduled abdominoplasty | No |