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

Primary Purpose

Acne Scars - Mixed Atrophic and Hypertrophic, Wrinkle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venus Viva
Sponsored by
Venus Concept
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring acne scars, wrinkles, rhytids, fractional RF

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Laser and Skin Surgery Center of Northern California

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Device: Venus Viva

Outcomes

Primary Outcome Measures

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.
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).

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 - 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.
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.
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.

Full Information

First Posted
August 13, 2019
Last Updated
June 8, 2021
Sponsor
Venus Concept
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1. Study Identification

Unique Protocol Identification Number
NCT04057768
Brief Title
Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
Official Title
Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (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
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.
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.

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, Wrinkle
Keywords
acne scars, wrinkles, rhytids, fractional RF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Device: Venus Viva
Intervention Type
Device
Intervention Name(s)
Venus Viva
Intervention 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.
Primary Outcome Measure Information:
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
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
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 and 12 Weeks Post- Final Treatment
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles. 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: Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). Subjects with any implantable metal device in the treatment area Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance. Current or history of any kind of cancer, or dysplastic nevi 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 following a prophylactic regime. 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 prior to treatment or as per investigators discretion. 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.
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
Laser and Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

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

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