Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles

• Sponsor: Venus Concept (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04057768
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Scars - Mixed Atrophic and Hypertrophic; Wrinkle	Device: Venus Viva	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
• Actual Study Start Date: Aug 19, 2019
• Actual Primary Completion Date: Mar 3, 2020
• Actual Study Completion Date: Mar 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention Device: Venus Viva	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser and Skin Surgery Center of Northern California	Sacramento	California	United States	95816

Sponsors and Collaborators

• Venus Concept

Investigators

• Study Director: Matthew Gronski, Venus Concept

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2019

More Information

Publications

None provided.

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT04057768
• Other Study ID Numbers: VI0919
• First Posted: Aug 15, 2019
• Last Update Posted: Jun 29, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Venus Concept: acne scars; wrinkles; rhytids; fractional RF
• Additional relevant MeSH terms: Acne Vulgaris; Hypertrophy

Study Results

Participant Flow

Arm/Group Title	Venus Viva™ Device
Arm/Group Description	Venus Viva™ Device: 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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	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.
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.7 (8.4)
Sex: Female, Male (Count of Participants)
Female	9 90%
Male	1 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	10 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	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.
Measure Participants	10
Baseline	5.97 (0.20)
12-weeks	5.78 (0.22)

2. Primary Outcome

Title	Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Error) [units on a scale]	0.4 (0.1)

3. Secondary Outcome

Title	Subject Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	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.
Measure Participants	10
6-weeks	3.22 (0.22)
12-weeks	3.20 (0.25)

4. Secondary Outcome

Title	Subject Scale - Wong Baker FACES Pain Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Error) [units on a scale]	3.93 (0.39)

5. Secondary Outcome

Title	Subject Scale - 5 Point Scale for Treatment Tolerability
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Error) [units on a scale]	3.10 (0.10)

6. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	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.
Measure Participants	10
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention
Arm/Group Description	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.
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.