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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057768
Recruitment Status : Completed
First Posted : August 15, 2019
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Venus Concept

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.

Condition or disease Intervention/treatment Phase
Acne Scars - Mixed Atrophic and Hypertrophic Wrinkle Device: Venus Viva Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
Actual Study Start Date : August 19, 2019
Actual Primary Completion Date : March 3, 2020
Actual Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment [ Time Frame: 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.


  2. Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment [ Time Frame: 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 :
  1. Subject Satisfaction [ Time Frame: 6 and 12 Weeks Post- Final Treatment ]

    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.


  2. Subject Scale - Wong Baker FACES Pain Scale [ Time Frame: 12 Weeks Post-Final Treatment ]

    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.


  3. Subject Scale - 5 Point Scale for Treatment Tolerability [ Time Frame: 8 Weeks Post-Final Treatment ]

    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.


  4. Number of Participants With Treatment-Related Adverse Events [ Time Frame: Up to 12 Weeks Post-Treatment ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057768


Locations
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United States, California
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
Sponsors and Collaborators
Venus Concept
Investigators
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Study Director: Matthew Gronski Venus Concept
  Study Documents (Full-Text)

Documents provided by Venus Concept:
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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT04057768    
Other Study ID Numbers: VI0919
First Posted: August 15, 2019    Key Record Dates
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Venus Concept:
acne scars
wrinkles
rhytids
fractional RF
Additional relevant MeSH terms:
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Acne Vulgaris
Hypertrophy
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pathological Conditions, Anatomical