Clinical Evaluation of Fractional Radiofrequency for the... | NCT03767153

NCT03767153

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
80 pin applicator	Experimental		Device: Venus Viva
160 pin applicator	Active Comparator		Device: Venus Viva

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venus Viva	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Eligibility Module

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.

Name	Affiliation	Role
Matthew Gronski	Venus Concept	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Leavitt Medical Associates of Florida d/b/a Ameriderm Research		Port Orange	Florida	32127	United States

Arm/Group Information

ID	Title	Description
FG000	80 Pin Applicator	Venus Viva: 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.
FG001	160 Pin Applicator	Venus Viva: 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	80 Pin Applicator	Venus Viva: 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

Posted

Mean

Standard Error

score on a scale

12 Weeks Post-Final Treatment

ID	Title	Description
OG000	80 Pin Applicator	Venus Viva: 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	80 Pin Applicator	Venus Viva: 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.