Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

• ClinicalTrials.gov Identifier: NCT03831477
• Recruitment Status: Completed
• First Posted: February 5, 2019
• Last Update Posted: April 2, 2021
• Sponsor: Venus Concept
• Information provided by (Responsible Party): Venus Concept

Study Description

Brief Summary:

Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.

Condition or disease	Intervention/treatment	Phase
Rhytides; Wrinkle	Device: Venus Viva	Not Applicable

Detailed Description:

The study will evaluate 15 subjects requesting treatment of their 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. An additional histological analysis will be conducted including up to 12 of the participating subjects.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, single centre, evaluator-blind study
• Masking: Single (Outcomes Assessor)
• Masking Description: Evaluator blinded assessment of photographs
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
• Actual Study Start Date: December 12, 2018
• Actual Primary Completion Date: August 9, 2019
• Actual Study Completion Date: August 9, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 80 pin applicator	Device: Venus Viva; The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
Active Comparator: 160 pin applicator	Device: Venus Viva; The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.

Outcome Measures

Primary Outcome Measures :

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

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.
2. Histology Assessment [ Time Frame: Up to 12 Weeks Post-Final Treatment ]
   Image analysis to observe histological changes in a treated area at baseline, immediately post-treatment, 1 week and 12 weeks post treatment.
3. Subject Scale - Visual Analog Scale for Pain [ 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 cm visual analog scale (VAS)
4. Subject Scale - 5 Point Scale for Treatment Tolerability [ 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
5. Incidence of Treatment-Related Adverse Events [ Time Frame: Up to 12 Weeks Post-Final Treatment ]
   Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.

Eligibility Criteria

• 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 facial 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. 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. ibuprofen-containing 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.

Contacts and Locations

Locations

United States, New York

Sadick Research Group

New York, New York, United States, 10075

Sponsors and Collaborators

Venus Concept

Investigators

• Study Director: Matthew Gronski; Venus Concept

  Study Documents (Full-Text)

Documents provided by Venus Concept:

Study Protocol and Statistical Analysis Plan  [PDF] October 9, 2018

More Information

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT03831477
• Other Study ID Numbers: VI1218
• First Posted: February 5, 2019
• Last Update Posted: April 2, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Venus Concept:

fractional radiofrequency; fractional RF; wrinkles; facial wrinkles