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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Scars - Mixed Atrophic and Hypertrophic; Wrinkle
• Intervention / Treatment: Device: Venus Viva

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Laser and Skin Surgery Center of Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Weeks Post-Final Treatment
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).	12 Weeks Post-Final Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 and 12 Weeks Post- Final Treatment
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.	12 Weeks Post-Final Treatment
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.	8 Weeks Post-Final Treatment
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.	Up to 12 Weeks Post-Treatment

Collaborators and Investigators

• Sponsor: Venus Concept

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: wrinkles; rhytids; acne scars; fractional RF
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Hypertrophy
• Other Study ID Numbers: VI0919

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes