Wrinkles Clinical Trial
Official title:
Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-Invasive Treatment of Wrinkles and Rhytides
Verified date | March 2015 |
Source | El. En. SpA |
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 | 51 |
Est. completion date | May 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - ICA signed by the subject. - Healthy male or female subjects 30-60 ys of age. - Having at least 2 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 treat and FU schedule and the post-treat 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 study Exclusion Criteria: - Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding. Females of childbearing potential must agree to take a urine pregnancy test (must be negative) at the Screening visit. Females of childbearing potential include anyone who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal for more than 2 years. - Having any active electrical implant anywhere in the body - Having a permanent implant in the treated area or an injected chemical substance. - Having a history of diseases stimulated by heat unless treatment is conducted following a prophylactic regimen. - Use of non-steroidal anti-inflammatory drugs 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 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 or collagen/Hyaluronic Acid 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. - History of keloid scarring or of abnormal wound healing. - Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course. - History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. - History of epidermal or dermal disorders. - History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. - Suffering from hormonal imbalance, as per the Investigator's discretion. - Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course. - Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions. - Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders. - Vascular lesion, tattoo or permanent make-up in the treated area. - Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. - Participation in a study of another device or drug within 1 month prior to enrollment or during the study. - As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Chernoff Plastic Surgery & Laser Center | Indianapolis | Indiana |
United States | Park Avenue SmartLipo | New York | New York |
Lead Sponsor | Collaborator |
---|---|
El. En. SpA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes to the Surface by Visual and Photographic Analysis. | 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. Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale. Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe |
3 Month FU | No |
Secondary | Patient Satisfaction and Comfort of the Treatment. | At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment. | Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU | No |
Secondary | Adverse Events. | At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then. | Subjects will be followed for the duration of the study, and expected average of 20 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01984619 -
Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles
|
N/A | |
Completed |
NCT01713985 -
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
|
N/A | |
Recruiting |
NCT01586819 -
Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
|
Phase 3 | |
Completed |
NCT05254210 -
Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device
|
N/A | |
Completed |
NCT02604641 -
Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin
|
N/A | |
Completed |
NCT01460927 -
TriActive+ Radiofrequency (RF) for Non-invasive Treatment of Wrinkles & Rhytides
|
N/A | |
Completed |
NCT01519934 -
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
|
N/A | |
Completed |
NCT03811756 -
The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters
|
N/A | |
Completed |
NCT04988412 -
The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters
|
N/A | |
Completed |
NCT02913547 -
Silk'n HST for Wrinkle Reduction - Clinical Study Protocol
|
N/A | |
Active, not recruiting |
NCT02019004 -
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
|
N/A | |
Completed |
NCT02340078 -
A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume in Nasolabial Fold Injection
|
N/A | |
Completed |
NCT01283464 -
Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles
|
Phase 2 | |
Completed |
NCT01034956 -
Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
|
N/A | |
Completed |
NCT02425943 -
Sculptra Aesthetic Post-Approval Study
|
Phase 4 | |
Recruiting |
NCT05847530 -
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
|
N/A | |
Enrolling by invitation |
NCT01847066 -
Epidermal Delivery of Ani-Aging Ingredients
|
N/A | |
Completed |
NCT01297634 -
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
|
Phase 4 | |
Completed |
NCT05011461 -
The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles
|
N/A | |
Completed |
NCT03460860 -
Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
|
N/A |