Wrinkles Clinical Trial
Official title:
Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-invasive Treatment of Wrinkles & Rhytides
Verified date | June 2014 |
Source | Deka Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.
Status | Completed |
Enrollment | 25 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Southwest Medical Group Plastic Surgery | Vancouver | Washington |
Lead Sponsor | Collaborator |
---|---|
Deka Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fitzpatrick Classification of Wrinkling and Degree of Elastosis. | At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles. Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42) Score Wrinkling & Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) |
Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU | No |
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