Status:
COMPLETED
TriActive+ Radiofrequency (RF) for Non-invasive Treatment of Wrinkles & Rhytides
Lead Sponsor:
Deka Medical, Inc.
Conditions:
Wrinkles
Rhytides
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary e...
Detailed Description
Collagen varies genetically and structurally. Collagen breakdown increases with chronological age and photoaging. While fibroblasts normally replace damaged collagen fibers with new ones, the ability ...
Eligibility Criteria
Inclusion
- Informed consent agreement signed by the subject.
- Healthy male or female subjects 30-60 years of age.
- Having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Exclusion
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding.
- 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, or an injected chemical substance.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Use of retinoids, antioxidants or skin nourishing supplements within 1 month of treatment or during the study.
- Having received a facial within 1 month of treatment or during the study.
- Having received a facial dermabrasion or chemical peel treatment within 2 months of treatment or during the study.
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- Having received Botox in the treated area within 6 months of treatment or during the study.
- Having received collagen/Hyaluronic Acid (HA) in the treated area within a year of treatment or during the study.
- Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study.
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- Having ever received fat injections or other methods of augmentation with injected or implanted material in the treated area or planning to during the study.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01460927
Start Date
October 1 2011
End Date
April 1 2012
Last Update
July 4 2014
Active Locations (1)
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1
Southwest Medical Group Plastic Surgery
Vancouver, Washington, United States, 98664