Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles

The need for cosmetic facial enhancement procedures with minimal down time and low risk has
led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers
were developed, which remove the full skin surface in a controlled manner1,2. However, the
prolonged recovery and the significant risks prompted the development of fractional lasers
which ablate the skin in a fractional manner, leaving untreated areas to improve healing
process3. In the past few years, fractional RF systems have been introduced that enable
controlled skin resurfacing accompanied with dermal collagen remodeling4,5,6. The new 3F
Applicator (A3F, trade name TriFractional) from Pollogen™ is designed to enable skin
resurfacing and treatment of wrinkles using radiofrequency energy.

The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation
and resurfacing of the skin, and for the treatment of facial wrinkles. This study was
designed in order to evaluate the safety and efficacy of the A3F for treatment of facial
wrinkles.

Inclusion Criteria:

1. Subject read, understood and signed the Consent Form

2. Healthy female/male aged 35 65 years,

3. Fitzpatrick wrinkle classification score 3 and above

4. Fitzpatrick skin type 2-5

5. Subject is capable of reading, understanding and following instructions of the
procedure to be applied.

6. Subject is able and willing to comply with the treatment and follow-up schedule.

Exclusion Criteria:

1. Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any
other internal electric device or patient who had an implant in the past.

2. Subject has metal or other implants in the treatment area (Not including dental
fillings, implants and crowns).

3. Subject has current or history of cancer, especially skin cancer or premalignant moles
or is undergoing any form of treatment for active cancer.

4. Subject has severe concurrent conditions such as epilepsy, lupus or cardiac disorders.

5. Subject has poorly controlled endocrine disorders such as diabetes.

6. Subject is female who is pregnant, lactating, or plans to become pregnant during the
study period or had given birth less than 6 months ago.

7. Subject has an impaired immune system due to immunosuppressive diseases such as HIV or
AIDS, or use of immunosuppressive medications.

8. Subject has a condition that could be negatively affected by heat, including any
history of diseases stimulated by heat, such as recurrent Herpes Simplex (in the
treatment area).

9. Subject has diminished or exaggerated perception of temperature changes.

10. Subject has significant concurrent skin conditions affecting areas to be treated such
as sores, hemorrhages or risk of hemorrhages, septic conditions, psoriasis, eczema and
rash as well as very dry and fragile skin.

11. Subject has history of collagen disorders, keloid formation and abnormal wound
healing.

12. Subject has had previous invasive/ablative procedures in the areas to be treated
within 3 months prior to initial treatment or plans on such treatment during the
course of the study, or before complete healing has occurred.

13. Subject has had Botox injections in the treatment area within 6 months prior to
initial treatment

14. Subject has had natural fillers within 9 months prior to initial treatment

15. Subject has synthetic fillers, injected chemical substance or gold/plastic threads in
the treatment area.

16. Subject takes or has taken medications, herbal preparations, food supplements or
vitamins that might cause fragile skin or impaired skin healing such as prolonged
steroid regime, tetracyclines, or St. John's Wort for the last 3 months.

17. Subject has used oral isotretinoin (Accutane or Roaccutan) within 6 months prior to
study enrollment or plans use during the course of the study.

18. Subject has history of bleeding coagulopathies or use of anticoagulants.

19. Use of non-steroidal anti inflammatory drugs (NSAIDS, e.g. ibuprofen containing
agents) one week before and after each treatment session prior to treatment

20. Tattoo or permanent makeup in the treated area

21. Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh
tanning in areas to be treated or is unlikely to refrain from excessive tanning during
the study.

22. Concurrent participation in any other study.

23. Subject has mental disorders that in the opinion of the Investigator would be
interfere with ability to comply with the study requirements.

24. Subject is allergic to the topical anesthetic used in this study.