Back to resultsClinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venus Viva MD
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring acne scarring, acne scar, fractional radiofrequency, fractional RF, FRF
Eligibility Criteria
Inclusion Criteria:
- Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their 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 systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofencontaining 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
- Sadick Research Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
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. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Outcomes
Primary Outcome Measures
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Secondary Outcome Measures
Treatment Pain
Subject's assessment of discomfort and pain assessed immediately 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).
Subject Scale - 5 Point Scale for Treatment Tolerability
Subject's assessment of treatment tolerability as measured by a 5 point scale. Participants were asked about their treatment tolerability level immediately 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
NCT04827680
Brief Title
Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction 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
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (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
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 the progress of 20 subjects requesting treatment of 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 - Mixed Atrophic and Hypertrophic
Keywords
acne scarring, acne scar, fractional radiofrequency, fractional RF, FRF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Blinded evaluation of photographs taken at baseline and at 6, 12 weeks post final treatment by independent evaluators.
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
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. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Intervention Type
Device
Intervention Name(s)
Venus Viva MD
Intervention Description
The Venus Viva™ MD 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. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Primary Outcome Measure Information:
Title
Subject Satisfaction
Description
Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Time Frame
12 Weeks Post-Final Treatment
Secondary Outcome Measure Information:
Title
Treatment Pain
Description
Subject's assessment of discomfort and pain assessed immediately 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).
Time Frame
Average of all treatments
Title
Subject Scale - 5 Point Scale for Treatment Tolerability
Description
Subject's assessment of treatment tolerability as measured by a 5 point scale. Participants were asked about their treatment tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
Time Frame
Average of all treatments
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 over 21 years of age who are seeking treatment and reduction of their 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 systemic retinoids within six months or topical retinoids within three 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
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring
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