Clinical trial NCT03831477: Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Official title: Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhytides
Wrinkle
Keywords: fractional radiofrequency
fractional RF
wrinkles
facial wrinkles
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single centre, evaluator-blind study
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline
timeFrame: 12 Weeks Post Final Treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 12 Weeks Post-Final Treatment
measure: Subject Scale - Visual Analog Scale for Pain
timeFrame: An average of all 3 treatments
measure: Subject Scale - 5 Point Scale for Treatment Tolerability
timeFrame: An average of all 3 treatments
Other outcomes:
Locations:
city: New York
country: United States
facility: Sadick Research Group
state: New York
Study officials:
affiliation: Venus Concept
name: Matthew Gronski
role: STUDY_DIRECTOR
References: