Acne Scars - Mixed Atrophic and Hypertrophic, Wrinkle
Conditions
Keywords
acne scars, wrinkles, rhytids, fractional RF
Brief summary
The objective of this clinical study is to evaluate the efficacy of fractional RF for the treatment and reduction of acne scarring or facial wrinkles.
Detailed description
Prospective, single centre, evaluator-blind, split face study of the efficacy of fractional radiofrequency (RF) for the treatment and reduction of acne scarring and facial wrinkles. The study will evaluate the progress of 15 subjects requesting treatment of scarring or 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.
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.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or 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. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 2. Subjects with any implantable metal device in the treatment area 3. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance. 4. Current or history of any kind of cancer, or dysplastic nevi 5. Severe concurrent conditions, such as cardiac disorders. 6. Pregnancy or intending to become pregnant during the study and nursing. 7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 9. Poorly controlled endocrine disorders, such as diabetes. 10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 12. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin). 13. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. 14. Use of isotretinoin (Accutane®) or other systemic retinoids within six months prior to treatment or as per investigators discretion. 15. Any surgical procedure in the treatment area within the last six months or before complete healing. 16. Treating over tattoo or permanent makeup. 17. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment | 12 Weeks Post-Final Treatment | Evaluate the efficacy of overall facial wrinkles improvement assessed live by the Investigator and a subject assessment of facial appearance including the Fitzpatrick Wrinkle and Elastosis Scale (FWES). The FWES is a 9 point scale. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were: a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis (\[indvidual papules with yellow translucency under direct lighting\] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome. |
| Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment | 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 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 - Wong Baker FACES Pain Scale | 12 Weeks Post-Final Treatment | Subject's assessment of discomfort and pain after treatments as measured by a 10 point Wong-Baker FACES Pain Scale The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 (no pain) to 10 (most pain). Possible responses, 9 to 10 shows Hurts Worst, 7 to 8 shows Hurts Whole Lot, 5 to 6 shows Hurts Even More, 3 to 4 shows Hurts Little More, 1 to 2 shows Hurts Little Bit, 0 shows No Hurt. |
| Subject Scale - 5 Point Scale for Treatment Tolerability | 8 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. |
| Number of Participants With Treatment-Related Adverse Events | Up to 12 Weeks Post-Treatment | Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment. A treatment-related adverse event was any untoward medical occurrence attributed to the device in a participant who received treatment. Relatedness to the device was assessed by the investigator. |
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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.4 |
| 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 | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 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).
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment | 0.4 units on a scale | Standard Error 0.1 |
Primary
Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment
Evaluate the efficacy of overall facial wrinkles improvement assessed live by the Investigator and a subject assessment of facial appearance including the Fitzpatrick Wrinkle and Elastosis Scale (FWES). The FWES is a 9 point scale. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were: a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis (\[indvidual papules with yellow translucency under direct lighting\] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome.
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment | Baseline | 5.97 units on a scale | Standard Deviation 0.2 |
| Intervention | Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment | 12-weeks | 5.78 units on a scale | Standard Deviation 0.22 |
Secondary
Number of Participants With Treatment-Related Adverse Events
Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment. A treatment-related adverse event was any untoward medical occurrence attributed to the device in a participant who received treatment. Relatedness to the device was assessed by the investigator.
Time frame: Up to 12 Weeks Post-Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Treatment-Related Adverse Events | 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 and 12 Weeks Post- Final Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Subject Satisfaction | 6-weeks | 3.22 units on a scale | Standard Error 0.22 |
| Intervention | Subject Satisfaction | 12-weeks | 3.20 units on a scale | Standard Error 0.25 |
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: 8 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Subject Scale - 5 Point Scale for Treatment Tolerability | 3.10 units on a scale | Standard Error 0.1 |
Secondary
Subject Scale - Wong Baker FACES Pain Scale
Subject's assessment of discomfort and pain after treatments as measured by a 10 point Wong-Baker FACES Pain Scale The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 (no pain) to 10 (most pain). Possible responses, 9 to 10 shows Hurts Worst, 7 to 8 shows Hurts Whole Lot, 5 to 6 shows Hurts Even More, 3 to 4 shows Hurts Little More, 1 to 2 shows Hurts Little Bit, 0 shows No Hurt.
Time frame: 12 Weeks Post-Final Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Subject Scale - Wong Baker FACES Pain Scale | 3.93 units on a scale | Standard Error 0.39 |