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 50 treatment sites in subjects requesting treatment of their 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 applicator 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
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded assessment of photographs taken at baseline and 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 22 years of age or over who are seeking treatment and reduction of their facial 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 retinoids within six 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 |
|---|---|---|
| Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks. | 12 Weeks Post-Final Treatment | Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a seven-grade subjective test. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 6 Weeks and 12 Weeks Post- Final Treatment | Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 Weeks and 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Participant were asked their satisfaction level post treatment. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied. |
| Subject Scale - Visual Analog Scale for Pain | 12 Weeks Post-Final Treatment | Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain). |
| Number of Participants With Treatment-Related Adverse Events [Safety] | Up to 12 Weeks Post-Final Treatment | Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment. |
| Subject Scale - 5 Point Scale for Treatment Tolerability | 12 Weeks Post-Final Treatment | Subject's assessment of treatment tolerability as measured by a 5 point scale. Participant were asked their tolerability level post treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 80 Pin Applicator Venus Viva: The Venus Viva™ fractional RF applicator 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. | 14 |
| 160 Pin Applicator Venus Viva: The Venus Viva™ fractional RF applicator 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. | 11 |
| Total | 25 |
Baseline characteristics
| Characteristic | 80 Pin Applicator | Total | 160 Pin Applicator |
|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 13.5 | 45.7 years STANDARD_DEVIATION 12 | 45.0 years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Region of Enrollment United States | 14 participants | 25 participants | 11 participants |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 11 |
| other Total, other adverse events | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 0 / 14 | 0 / 11 |
Outcome results
Primary
Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.
Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a seven-grade subjective test. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80 Pin Applicator | Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks. | 1.06 score on a scale | Standard Error 0.13 |
| 160 Pin Applicator | Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks. | 0.85 score on a scale | Standard Error 0.13 |
Secondary
Number of Participants With Treatment-Related Adverse Events [Safety]
Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.
Time frame: Up to 12 Weeks Post-Final Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 80 Pin Applicator | Number of Participants With Treatment-Related Adverse Events [Safety] | 0 Participants |
| 160 Pin Applicator | Number of Participants With Treatment-Related Adverse Events [Safety] | 0 Participants |
Secondary
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 Weeks and 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Participant were asked their satisfaction level post treatment. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Time frame: 6 Weeks and 12 Weeks Post- Final Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 Pin Applicator | Subject Satisfaction | 6-weeks | 3.25 score on a scale | Standard Error 0.18 |
| 80 Pin Applicator | Subject Satisfaction | 12-weeks | 3.18 score on a scale | Standard Error 0.18 |
| 160 Pin Applicator | Subject Satisfaction | 6-weeks | 3.55 score on a scale | Standard Error 0.21 |
| 160 Pin Applicator | Subject Satisfaction | 12-weeks | 3.36 score on a scale | Standard Error 0.24 |
Secondary
Subject Scale - 5 Point Scale for Treatment Tolerability
Subject's assessment of treatment tolerability as measured by a 5 point scale. Participant were asked their tolerability level post treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80 Pin Applicator | Subject Scale - 5 Point Scale for Treatment Tolerability | 3.36 score on a scale | Standard Error 0.07 |
| 160 Pin Applicator | Subject Scale - 5 Point Scale for Treatment Tolerability | 3.48 score on a scale | Standard Error 0.06 |
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). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80 Pin Applicator | Subject Scale - Visual Analog Scale for Pain | 2.23 cm | Standard Error 0.26 |
| 160 Pin Applicator | Subject Scale - Visual Analog Scale for Pain | 2.05 cm | Standard Error 0.27 |