Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring

• ClinicalTrials.gov Identifier: NCT03821324
• Recruitment Status: Active, not recruiting
• First Posted: January 29, 2019
• Last Update Posted: October 21, 2019
• 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 acne scarring. The study will evaluate the progress of 15 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	Device: Venus Viva	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 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: December 11, 2018
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: December 1, 2019

Arms and Interventions

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. 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.

Outcome Measures

Primary Outcome Measures :

1. Acne Scar Improvement [ Time Frame: 6 and 12 Weeks Post-Final Treatment ]
   Change in acne scarring at 6 weeks and 12 weeks post-intervention compared to baseline as assessed by blinded evaluators by photographic assessment utilizing a 7 point Global Aesthetic Improvement Scale (GAIS) for acne scarring.

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. Subject Scale - Visual Analog Scale for Pain [ Time Frame: Up to 3 Months Post Enrollment ]
   Subjects' assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS).
3. 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.
4. Subject Scale - 5 Point Scale for Treatment Tolerability [ Time Frame: Up to 3 Months Post Enrollment ]
   Subjects' assessment of treatment tolerability as measured by a 5 point scale

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 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. 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: Paul Cardarelli; Venus Concept

More Information

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT03821324
• Other Study ID Numbers: VI1118
• First Posted: January 29, 2019
• Last Update Posted: October 21, 2019
• Last Verified: October 2019

• 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

Additional relevant MeSH terms:

Cicatrix; Fibrosis; Pathologic Processes