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

NCT01597323 | Completed

• 1 other identifier: DC84611
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 3

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

Keywords

Wrinkle Reduction; Skin Resurfacing; Skin Texture Improvement

Study Arms (1)

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

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Healthy male or female between the ages of 35 and 60
• Non-smoker
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (3)

Sanctuary Medical Aesthetic Center

Boca Raton, Florida, 33431, United States

Location

The Maryland Laser, Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Cosmetic & Reconstructive Plastic Surgery

Great Neck, New York, 11021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Optional biopsy, for consenting subjects, of facial skin tissue from areas directly in front of ear (Pre-Auricular)

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: October 25, 2011
• Primary Completion: October 14, 2014
• Study Completion: October 14, 2014
• Last Updated: December 6, 2019

Record last verified: 2019-12

Locations

US (3)