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Trial record 64 of 339 for:    acne AND facial

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

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ClinicalTrials.gov Identifier: NCT04057768
Recruitment Status : Active, not recruiting
First Posted : August 15, 2019
Last Update Posted : September 27, 2019
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 : 15 participants
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
Estimated Primary Completion Date : July 19, 2020
Estimated Study Completion Date : July 19, 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. Change n Acne Scarring [ Time Frame: 6 and 12 Weeks Post-Treatment ]
    Change in acne scarring at 6 weeks and 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 5 point Global Aesthetic Improvement Scale (GAIS)

  2. Change in Facial Wrinkles [ Time Frame: 6 and 12 Weeks Post-Treatment ]
    Change in facial wrinkles at 6 weeks and 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9 point Fitzpatrick Wrinkle and Elastosis Scale (FWES)


Secondary Outcome Measures :
  1. Subject Satisfaction: Subject Satisfaction Scale [ Time Frame: 6 and 12 Weeks Post-Treatment ]
    Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 weeks and 12 weeks post-treatment.

  2. Subject Scale - Wong Baker FACES Pain Scale [ Time Frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits ]
    Subject's assessment of discomfort and pain after treatments as measured by a 10 point Wong-Baker FACES Pain Scale

  3. Subject Scale - 5 Point Scale for Treatment Tolerability: 5 point scale [ Time Frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits ]
    Subject's assessment of treatment tolerability as measured by a 5 point scale

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



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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: Paul Cardarelli Venus Concept

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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT04057768     History of Changes
Other Study ID Numbers: VI0919
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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