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

December 5, 2019 updated by: Candela Corporation

Safety and Efficacy Evaluation of the eTWO System for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

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

Study Overview

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Boca Raton, Florida, United States, 33431
        • Sanctuary Medical Aesthetic Center
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • The Maryland Laser, Skin and Vein Institute
    • New York
      • Great Neck, New York, United States, 11021
        • Cosmetic & Reconstructive Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 25, 2011

Primary Completion (ACTUAL)

October 14, 2014

Study Completion (ACTUAL)

October 14, 2014

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (ESTIMATE)

May 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DC84611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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