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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pollogen
ClinicalTrials.gov Identifier:
NCT01566396
First received: March 27, 2012
Last updated: October 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Facial Wrinkles
Device: A3F

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles

Further study details as provided by Pollogen:

Primary Outcome Measures:
  • To evaluate the safety of the 3F Applicator (A3F) for treatment of facial wrinkles. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • To evaluate the efficacy of the 3F Applicator (A3F) for treatment of facial wrinkles. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A3F
A3F, Fractional RF treatment
Device: A3F
A3F fractional RF treatments for facial wrinkles

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566396

Locations
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Research Across America
Plano, Texas, United States, 75093
Sponsors and Collaborators
Pollogen
Investigators
Study Director: Mira Barki, PhD Pollogen Ltd.
  More Information

No publications provided

Responsible Party: Pollogen
ClinicalTrials.gov Identifier: NCT01566396     History of Changes
Other Study ID Numbers: PC210117_F, rev. 01
Study First Received: March 27, 2012
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pollogen:
Fractional,
RF,
Wrinkles
Safety
Efficacy
treatment

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014