Safety & Efficacy Evaluation of a Radiofrequency & Laser/Light System for Improvement of Skin Texture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Candela Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Candela Corporation
ClinicalTrials.gov Identifier:
NCT01597323
First received: May 10, 2012
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light based device for the treatment of facial wrinkles.


Condition
Skin Texture Irregularities
Facial Skin Wrinkles

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Safety and Efficacy Evaluation of the eTWO System for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

Further study details as provided by Candela Corporation:

Biospecimen Retention:   Samples With DNA

Optional biopsy, for consenting subjects, of facial skin tissue from areas directly in front of ear (Pre-Auricular)


Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment Group
Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial photodamage (sun damage) and presence of mild to moderate facial wrinkling

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial photodamage (sun damage) and presence of mild to moderate facial wrinkling

Criteria

Inclusion Criteria:

  1. Healthy male or female between the ages of 35 and 60
  2. Non-smoker
  3. Fitzpatrick skin type I-VI
  4. Fitzpatrick Degree of Elastosis Score of 2-6 (inclusive)
  5. Presence of mild to moderate photodamage, such as solar lentigines, dyschromia and/or presence of mild to moderate facial wrinkling
  6. Able and willing to comply with all visit, treatment and evaluation schedules and requirements
  7. Able to understand and provide written Informed Consent
  8. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

Exclusion Criteria:

  1. Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit;
  2. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
  3. Having a permanent implant in the treated area, such as metal plates and screws
  4. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
  5. Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study
  6. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study
  7. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
  8. Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study
  9. Prior skin treatment with laser in treated area within 3 months of initial treatment or during the course of the study
  10. Prior use of Botox, collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 3-4 weeks of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants
  11. Prior ablative resurfacing procedure, brow lift, blepharoplasty or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study
  12. Any other surgery in treated area within 12 months of initial treatment or during the course of the study
  13. History of keloid formation or poor wound healing in a previously injured skin area
  14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity)
  15. Open laceration or abrasion of any sort on the area to be treated
  16. Active Herpes Simplex I at the time of treatment
  17. Multiple dysplastic nevi in the area to be treated
  18. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to the treatment (as per the subject 's physician discretion)
  19. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
  20. Having any form of active cancer at the time of enrollment and during the course of the study
  21. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process
  22. Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
  23. Tattoos, including cosmetic make-up tattoos, in the treatment area
  24. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse
  25. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597323

Locations
United States, Florida
Sanctuary Medical Aesthetic Center Recruiting
Boca Raton, Florida, United States, 33431
Contact: Diane Paquet    561-886-0970    dpaquet28@aol.com   
Principal Investigator: Jason N Pozner, MD         
United States, Maryland
The Maryland Laser, Skin and Vein Institute Completed
Hunt Valley, Maryland, United States, 21030
United States, New York
Cosmetic & Reconstructive Plastic Surgery Recruiting
Great Neck, New York, United States, 11021
Contact: Cindi Godt, RN    516-498-2804      
Principal Investigator: Alan H Gold, MD         
Sponsors and Collaborators
Candela Corporation
Investigators
Principal Investigator: Alan H Gold, MD Board Certified Plastic Surgeon, American Board of Plastic Surgeons
Principal Investigator: Robert Weiss, MD Board Certified Dermatologist, American Board of Medical Specialties
Principal Investigator: Jason N Pozner, MD Board Certified Plastic Surgeon, American Board of Plastic Surgeons
  More Information

No publications provided

Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT01597323     History of Changes
Other Study ID Numbers: DC84611
Study First Received: May 10, 2012
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Candela Corporation:
Wrinkle Reduction
Skin Resurfacing
Skin Texture Improvement

ClinicalTrials.gov processed this record on April 17, 2014