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

NCT ID: NCT04827680

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-06-13

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

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.

Group Type: EXPERIMENTAL

Venus Viva MD

Intervention Type: DEVICE

The Venus Viva™ MD 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.

Interventions

Venus Viva MD

The Venus Viva™ MD 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Gronski

Role: STUDY_DIRECTOR

Venus Concept

Locations

Sadick Research Group

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VI0121

Identifier Type: -

Identifier Source: org_study_id