Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles
|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|
- 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.
- 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.
|Study Start Date:||March 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
A3F, Fractional RF treatment
A3F fractional RF treatments for 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566396
|United States, Tennessee|
|Tennessee Clinical Research Center|
|Nashville, Tennessee, United States, 37215|
|United States, Texas|
|Research Across America|
|Plano, Texas, United States, 75093|
|Study Director:||Mira Barki, PhD||Pollogen Ltd.|