Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring

Conditions:Acne, Acne
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:22 - Any
Start Date:December 11, 2018
End Date:December 1, 2019
Contact:Louie Cabigao, CCRP

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

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.

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

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

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

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

20. As per the practitioner's discretion, refrain from treating any condition which might
make it unsafe for the patient.
We found this trial at
911 Park Avenue
New York, New York 10075
Phone: 212-772-7242
New York, NY
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