Clinical trial NCT04057768: Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
Official title: Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Wrinkle
Keywords: acne scars
wrinkles
rhytids
fractional RF
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment
timeFrame: 12 Weeks Post-Final Treatment
measure: Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment
timeFrame: 12 Weeks Post-Final Treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 6 and 12 Weeks Post- Final Treatment
measure: Subject Scale - Wong Baker FACES Pain Scale
timeFrame: 12 Weeks Post-Final Treatment
measure: Subject Scale - 5 Point Scale for Treatment Tolerability
timeFrame: 8 Weeks Post-Final Treatment
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: Up to 12 Weeks Post-Treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
Study officials:
affiliation: Venus Concept
name: Matthew Gronski
role: STUDY_DIRECTOR
References: