Facial and Neck Rhytides
Conditions
Keywords
wrinkles, rhytides
Brief summary
Use of RF device to treat wrinkles of the neck
Detailed description
This is a prospective study evaluating the safety and efficacy of two treatments, spaced at 30 day intervals, using the Surgitron® Dual RF™ S5 with the Pellevé™ wrinkle treatment handpiece and Pellevé™ treatment gel for the treatment of neck wrinkles.
Interventions
DEVICEPelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator
two treatments spaced 30 days apart
Sponsors
Ellman International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 30-70 years of age * Subjects with clinical evidence of neck wrinkles moderate to severe in severity as specified by a grade 4-9 on the Fitzpatrick Wrinkle Assessment Scale. * Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. * Willingness and ability to provide written photo consent and adherence to photography procedures(i.e., removal of jewelry and makeup). * Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion criteria
* Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control. * Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study. * Subjects who have had prior exposure to any botulinum toxin for rhytids in the treatment area in the 6 months preceding study enrollment through the duration of the study. * Subjects who have had a prior cosmetic procedure to improve rhytids in the treatment area (i.e.,rhytidectomy, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment)within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography. * Microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study. * Active cut, wound, or infection on the skin. * Oral Isotretinon within the past 12 months. * Active HSV-1. * History of keloids or hypertrophic scarring. * Existing or history of skin malignancy in the treatment area during the past 12 months. * Existing or history of skin disease in the treatment area during the past 12 months. * History of collagen or vascular disease. * Subjects who have implantable pacemaker, automatic implantable defibrillator/ cadioversor (AICD), or any other implantable electric device. * Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics. * History of autoimmune disease. * History of any disease that inhibits pain sensation. * History of Diabetes I or II. * Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication. * Subjects who anticipate the need for surgery or overnight hospitalization during the study. * Subjects who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment or unreliability. * Enrollment in any active study involving the use of investigational devices or drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment | 90 days post treatment | Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study. The measurement is for percentage of patients who showed improvement |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 90 days post treatment | The rate of adverse events will be assessed throughout the duration of the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group All subjects enrolled were in the treatment group.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment
Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study. The measurement is for percentage of patients who showed improvement
Time frame: 90 days post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment | 74 percentage of participants |
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The rate of adverse events will be assessed throughout the duration of the study
Time frame: 90 days post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 participants |