Rhytides, Wrinkle
Conditions
Keywords
fractional radiofrequency, fractional RF, wrinkles, facial wrinkles
Brief summary
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Detailed description
The study will evaluate 15 subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment. An additional histological analysis will be conducted including up to 12 of the participating subjects.
Interventions
DEVICEVenus Viva
The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
Sponsors
Venus Concept
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluator blinded assessment of photographs
Intervention model description
Prospective, single centre, evaluator-blind study
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles. 2. Able to read, understand and voluntarily provide written Informed Consent. 3. Able and willing to comply with the treatment/follow-up schedule and requirements. 4. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
Exclusion criteria
1. Implantable defibrillators, cardiac pacemakers, and other metal implants 2. Subjects with any implantable metal device in the treatment area 3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 5. Current or history of any kind of cancer, or pre-malignant moles. 6. Severe concurrent conditions, such as cardiac disorders. 7. Pregnancy or intending to become pregnant during the study and nursing. 8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion. 10. Poorly controlled endocrine disorders, such as diabetes. 11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin). 14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. 15. Use of isotretinoin (Accutane®) or other systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion. 16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session. 17. Any surgical procedure in the treatment area within the last six months or before complete healing. 18. Treating over tattoo or permanent makeup. 19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. 20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline | 12 Weeks Post Final Treatment | Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 12 Weeks Post-Final Treatment | Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being very unsatisfied and 4 very satisfied. |
| Subject Scale - Visual Analog Scale for Pain | An average of all 3 treatments | Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being maximal pain. VAS was measured following each of the 3 treatments. |
| Subject Scale - 5 Point Scale for Treatment Tolerability | An average of all 3 treatments | Subject's assessment of treatment tolerability as measured by a 5-point scale with 4 being very tolerable and 0 very intolerable. VAS was measured following each of the 3 treatments. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Viva Treatment Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Viva Treatment |
|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline
Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.
Time frame: 12 Weeks Post Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viva Treatment | Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline | -0.10 units on a scale | Standard Error 0.12 |
Secondary
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being very unsatisfied and 4 very satisfied.
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viva Treatment | Subject Satisfaction | 2.5 units on a scale | Standard Deviation 1.3 |
Secondary
Subject Scale - 5 Point Scale for Treatment Tolerability
Subject's assessment of treatment tolerability as measured by a 5-point scale with 4 being very tolerable and 0 very intolerable. VAS was measured following each of the 3 treatments.
Time frame: An average of all 3 treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viva Treatment | Subject Scale - 5 Point Scale for Treatment Tolerability | 3.55 units on a scale | Standard Deviation 0.5 |
Secondary
Subject Scale - Visual Analog Scale for Pain
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being maximal pain. VAS was measured following each of the 3 treatments.
Time frame: An average of all 3 treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viva Treatment | Subject Scale - Visual Analog Scale for Pain | 3.2 units on a scale | Standard Deviation 2.2 |