Back to resultsClinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
Primary Purpose
Acne Scars
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venus Viva
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars focused on measuring acne scarring, acne scar, fractional radiofrequency, fractional RF
Eligibility Criteria
Inclusion Criteria:
- Healthy, male or female subjects 22 years of age or over who are seeking treatment and reduction of their facial acne scarring.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- 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:
- Implantable defibrillators, cardiac pacemakers, and other metal implants
- Subjects with any implantable metal device in the treatment area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- Current or history of any kind of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders.
- Pregnancy or intending to become pregnant during the study and nursing.
- Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- 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 .
- Poorly controlled endocrine disorders, such as diabetes.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
- Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
- Any surgical procedure in the treatment area within the last six months or before complete healing.
- Treating over tattoo or permanent makeup.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Sites / Locations
- Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
80 pin applicator
160 pin applicator
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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).
Number of Participants With Treatment-Related Adverse Events [Safety]
Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03767153
Brief Title
Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
Official Title
Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
December 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars
Keywords
acne scarring, acne scar, fractional radiofrequency, fractional RF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Blinded assessment of photographs taken at baseline and 6, 12 weeks post final treatment by independent evaluators.
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
80 pin applicator
Arm Type
Experimental
Arm Title
160 pin applicator
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Venus Viva
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.
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
Secondary Outcome Measure Information:
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 Weeks and 12 Weeks Post- Final Treatment
Title
Subject Scale - Visual Analog Scale for Pain
Description
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
Title
Number of Participants With Treatment-Related Adverse Events [Safety]
Description
Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.
Time Frame
Up to 12 Weeks Post-Final Treatment
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
12 Weeks Post-Final Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, male or female subjects 22 years of age or over who are seeking treatment and reduction of their facial acne scarring.
Able to read, understand and voluntarily provide written Informed Consent.
Able and willing to comply with the treatment/follow-up schedule and requirements.
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:
Implantable defibrillators, cardiac pacemakers, and other metal implants
Subjects with any implantable metal device in the treatment area
Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
Current or history of any kind of cancer, or pre-malignant moles.
Severe concurrent conditions, such as cardiac disorders.
Pregnancy or intending to become pregnant during the study and nursing.
Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
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 .
Poorly controlled endocrine disorders, such as diabetes.
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
Any surgical procedure in the treatment area within the last six months or before complete healing.
Treating over tattoo or permanent makeup.
Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Gronski
Organizational Affiliation
Venus Concept
Official's Role
Study Director
Facility Information:
Facility Name
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
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