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

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.

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles
• Intervention / Treatment: Device: A3F

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Plano, Texas, United States, 75093
      • Research Across America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A3F; A3F, Fractional RF treatment	Device: A3F; A3F fractional RF treatments for facial wrinkles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of the 3F Applicator (A3F) for treatment of facial wrinkles.	The safety of using the 3F Applicator (A3F) for treatment of facial wrinkles a will be established by physician's assessment/observation of adverse events. AEs will be tabulated by severity and relation to treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of the 3F Applicator (A3F) for treatment of facial wrinkles.	Efficacy of using the 3F Applicator (A3F) for treatment of facial wrinkles will be established by level of wrinkle reduction. The treated area will be photographed, using high-resolution macro photography prior to the treatments and at the follow up visits. The pre - and post-treatment photographs will be compared and scored by two independent uninvolved physicians.	6 months

Collaborators and Investigators

• Sponsor: Pollogen
• Investigators: Study Director: Mira Barki, PhD, Pollogen Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (ESTIMATE): March 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Safety; treatment; Efficacy; Wrinkles; Fractional,; RF,
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: PC210117_F, rev. 01