Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light
based device for the treatment of facial wrinkles.
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Full eligibility criteria for NCT01597323
Ages eligible for Study
35 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Healthy male or female between the ages of 35 and 60
Fitzpatrick skin type I-VI
Fitzpatrick Degree of Elastosis Score of 2-6 (inclusive)
Presence of mild to moderate photodamage, such as solar lentigines, dyschromia and/or presence of mild to moderate facial wrinkling
Able and willing to comply with all visit, treatment and evaluation schedules and requirements
Able to understand and provide written Informed Consent
Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
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;
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
Having a permanent implant in the treated area, such as metal plates and screws
Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study
Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study
Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study
Prior skin treatment with laser in treated area within 3 months of initial treatment or during the course of the study
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
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
Any other surgery in treated area within 12 months of initial treatment or during the course of the study
History of keloid formation or poor wound healing in a previously injured skin area
History of epidermal or dermal disorders (particularly if involving collagen or microvascularity)
Open laceration or abrasion of any sort on the area to be treated
Active Herpes Simplex I at the time of treatment
Multiple dysplastic nevi in the area to be treated
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)
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
Having any form of active cancer at the time of enrollment and during the course of the study
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
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
Tattoos, including cosmetic make-up tattoos, in the treatment area
Mentally incompetent, prisoner or evidence of active substance or alcohol abuse
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
All locations for NCT01597323
United States (3)
Sanctuary Medical Aesthetic Center
Boca Raton, Florida, United States, 33431
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The Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
Cosmetic & Reconstructive Plastic Surgery
Great Neck, New York, United States, 11021
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View full eligibility
Tris trial is registered with FDA with number: NCT01597323. The sponsor of the trial is Candela Corporation and it is looking for 150 volunteers for the current phase.
Official trial title: Safety and Efficacy Evaluation of the eTWO System for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
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