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Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

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: NCT04827680
Recruitment Status : Active, not recruiting
First Posted : April 1, 2021
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Venus Concept

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention 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.
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring
Actual Study Start Date : May 1, 2021
Actual Primary Completion Date : April 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: 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. 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.
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. 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 Measures :
  1. 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 - Visual Analog Scale for Pain [ Time Frame: 12 Weeks Post-Final Treatment ]

    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).


  3. Incidence of Treatment-Related Adverse Events [ Time Frame: 12 Weeks Post-Final Treatment ]
    Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.

  4. Subject Scale - 5 Point Scale for Treatment Tolerability [ Time Frame: 12 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.




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:   Yes
Criteria

Inclusion Criteria:

  1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring.
  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. Implantable defibrillators, cardiac pacemakers, and other metal implants
  2. Subjects with any implantable metal device in the treatment area
  3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
  4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
  5. Current or history of any kind of cancer, or pre-malignant moles.
  6. Severe concurrent conditions, such as cardiac disorders.
  7. Pregnancy or intending to become pregnant during the study and nursing.
  8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
  9. 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.
  10. Poorly controlled endocrine disorders, such as diabetes.
  11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
  12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
  13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
  14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
  15. 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.
  16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofencontaining agents) one week before and after each treatment session.
  17. Any surgical procedure in the treatment area within the last six months or before complete healing.
  18. Treating over tattoo or permanent makeup.
  19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
  20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

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): NCT04827680


Locations
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United States, New York
Sadick Research Group
New York, New York, United States, 10075
Sponsors and Collaborators
Venus Concept
Investigators
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Study Director: Matthew Gronski Venus Concept
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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT04827680    
Other Study ID Numbers: VI0121
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022

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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 scarring
acne scar
fractional radiofrequency
fractional RF
FRF
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes