Appearance of Facial Wrinkles
Conditions
Keywords
wrinkle, rhytide
Brief summary
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.
Detailed description
The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.
Interventions
DEVICEPelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
Sponsors
Ellman International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Females 35-60 years of age with Fitzpatrick Skin Color Type I-IV. * Subjects with clinical evidence of facial wrinkles mild to moderate in severity as specified by a grade 4-6 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 facial rhytids in the 6 months preceding study enrollment through the duration of the study. * Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, 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. * Ablative skin resurfacing on the glabellar area within the previous 6 months or during the study. * Retinoid, 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. * Any existing skin disease. * 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, non¬compliance 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 |
|---|---|---|
| Fitzpatrick Wrinkle Assessment | change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment. | Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease |
| Adverse Events | 90 days post treatment | The rate of adverse events occurring in treatment subjects will be assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Treatment Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System | 15 |
| Double Treatment Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System | 15 |
| Triple Treatment Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Single Treatment | Double Treatment | Triple Treatment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 10 Participants | 40 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 7.2 | 52 years STANDARD_DEVIATION 6.5 | 53 years STANDARD_DEVIATION 5.2 | 52 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment United States | 15 participants | 15 participants | 10 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 10 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 10 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 10 |
Outcome results
Primary
Adverse Events
The rate of adverse events occurring in treatment subjects will be assessed.
Time frame: 90 days post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Treatment | Adverse Events | 0 number of adverse events reported |
| Double Treatment | Adverse Events | 0 number of adverse events reported |
| Triple Treatment | Adverse Events | 0 number of adverse events reported |
Primary
Fitzpatrick Wrinkle Assessment
Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease
Time frame: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment | Fitzpatrick Wrinkle Assessment | 1.0 units on a scale, change in Fitzpatrick | Standard Deviation 0.98 |
| Double Treatment | Fitzpatrick Wrinkle Assessment | 1.5 units on a scale, change in Fitzpatrick | Standard Deviation 1.9 |
| Triple Treatment | Fitzpatrick Wrinkle Assessment | 1.1 units on a scale, change in Fitzpatrick | Standard Deviation 1.7 |