Acne Scars
Conditions
Keywords
acne scarring, acne scar, fractional radiofrequency, fractional RF
Brief summary
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate the progress of 15 subjects requesting treatment of acne scarring. 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.
Interventions
DEVICEVenus Viva
The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinded evaluation of photographs taken at baseline and at 6, 12 weeks post final treatment by independent evaluators.
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 acne scarring. 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 |
|---|---|---|
| Acne Scar Improvement | 12 weeks post-final treatment (approximately Week 20) | Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 12 weeks post-final treatment (approximately Week 20) | Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale (ranging from 0 Very Unsatisfied to 4 Very Satisfied) at 6 weeks and 12 weeks post-treatment. |
| Subject Scale - Visual Analog Scale for Pain | Immediately post-treatment at each treatment (average of all 3 treatments) | Subjects' 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 pain as bad as it can be. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score. |
| Treatment Tolerability | Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments) | Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Device: Venus Viva
Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 9 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Acne Scar Improvement
Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).
Time frame: 12 weeks post-final treatment (approximately Week 20)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12-weeks After Last Treatment | Acne Scar Improvement | 0.26 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 (ranging from 0 Very Unsatisfied to 4 Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Time frame: 12 weeks post-final treatment (approximately Week 20)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12-weeks After Last Treatment | Subject Satisfaction | 2.89 units on a scale | Standard Deviation 1.05 |
Secondary
Subject Scale - Visual Analog Scale for Pain
Subjects' 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 pain as bad as it can be. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score.
Time frame: Immediately post-treatment at each treatment (average of all 3 treatments)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12-weeks After Last Treatment | Subject Scale - Visual Analog Scale for Pain | 3.09 units on a scale | Standard Deviation 1.92 |
Secondary
Treatment Tolerability
Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable).
Time frame: Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12-weeks After Last Treatment | Treatment Tolerability | 3.51 units on a scale | Standard Deviation 0.45 |