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

NCT ID: NCT04057768

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2020-03-03

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.

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic; Wrinkle

Study Design

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

Study Groups

Intervention

Device: Venus Viva

Group Type: OTHER

Venus Viva

Intervention Type: DEVICE

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.

Interventions

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.

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 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Gronski

Role: STUDY_DIRECTOR

Venus Concept

Locations

Laser and Skin Surgery Center of Northern California

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VI0919

Identifier Type: -

Identifier Source: org_study_id