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

Facial Skin Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597323
• Other study ID #: DC84611
• Status: Completed
• Start date: October 25, 2011
• Est. completion date: October 14, 2014

Study information

• Verified date: December 2019
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 14, 2014
• Est. primary completion date: October 14, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Skin Wrinkles
• Skin Texture Irregularities

Locations

Country	Name	City	State
United States	Sanctuary Medical Aesthetic Center	Boca Raton	Florida
United States	Cosmetic & Reconstructive Plastic Surgery	Great Neck	New York
United States	The Maryland Laser, Skin and Vein Institute	Hunt Valley	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Country where clinical trial is conducted

United States,