Clinical trial NCT01597323: Safety & Efficacy Evaluation of a Radiofrequency & Laser/Light System for Improvement of Skin Texture
Official title: Safety and Efficacy Evaluation of the eTWO System for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Texture Irregularities
Facial Skin Wrinkles
Keywords: Wrinkle Reduction
Skin Resurfacing
Skin Texture Improvement
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 61
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Sanctuary Medical Aesthetic Center
state: Florida
city: Hunt Valley
country: United States
facility: The Maryland Laser, Skin and Vein Institute
state: Maryland
city: Great Neck
country: United States
facility: Cosmetic & Reconstructive Plastic Surgery
state: New York
Study officials:
affiliation: Board Certified Plastic Surgeon, American Board of Plastic Surgeons
name: Alan H Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Board Certified Dermatologist, American Board of Medical Specialties
name: Robert Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Board Certified Plastic Surgeon, American Board of Plastic Surgeons
name: Jason N Pozner, MD
role: PRINCIPAL_INVESTIGATOR
References: