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

NCT ID: NCT01597323

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-25
• Study Completion Date: 2014-10-14

Brief Summary

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

Conditions

Skin Texture Irregularities; Facial Skin Wrinkles

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan H Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Board Certified Plastic Surgeon, American Board of Plastic Surgeons

Robert Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Board Certified Dermatologist, American Board of Medical Specialties

Jason N Pozner, MD

Role: PRINCIPAL_INVESTIGATOR

Board Certified Plastic Surgeon, American Board of Plastic Surgeons

Locations

Sanctuary Medical Aesthetic Center

Boca Raton, Florida, United States

The Maryland Laser, Skin and Vein Institute

Hunt Valley, Maryland, United States

Cosmetic & Reconstructive Plastic Surgery

Great Neck, New York, United States

Countries

United States

Other Identifiers

DC84611

Identifier Type: -

Identifier Source: org_study_id