Evaluation of High Intensity Focused Fractional Radiofrequency Microneedling (HI-FRM) and Fractional Laser (FL) for Combination Treatment in Wrinkles, Texture, and Pigmentation of the Face and/or Neck

Background/Objective:  Normal aging leads to change in skin collagen structure and reduced elasticity that can result in wrinkles, texture and pigmentation changes.  With a variety of aesthetic treatment options available, combination treatment approaches has led to greater patient satisfaction and better quality of care. The purpose of this study is to evaluate the clinical outcomes of HI-FRM and FL combination treatment for improving wrinkles, texture and pigmentation of the face and/or neck.      

 

Methods: 22 subjects were enrolled (2 screen failures); 20 subjects received combination treatments. The treated cohort was comprised of non-Hispanic, Caucasian females with mean age of 56 years (range 38-72) and mean BMI of 24 (range 19-28). The majority of subjects presented with Fitzpatrick Skin Types II and III. Subjects received 3 combination treatments completed 30 days apart. Standardized photographs were taken at baseline and each follow-up. Improvement in wrinkles, texture and pigmentation was determined by masked, qualitative assessment of photographs at 90 days after last treatment compared to baseline. Clinician and Subject Global Aesthetic Improvement Scales (CGAIS, PGAIS), and a Patient Satisfaction Questionnaire were completed at 90 days after last treatment.

 

Results:  Fifty-four (54) device- or procedure-related events were reported, including erythema (46%), edema (35%), tenderness/soreness/sensitivity to touch (11%), petechia (4%), acne (2%) and folliculitis (2%).  The vast majority of events were categorized as Expected Treatment Effects (96%); two (4%) events were categorized as Adverse Events due to the events’ duration.  All events were reported as mild (92%) or moderate (8%) in severity. No serious adverse events have been reported. An analysis across all endpoints will be completed with final data.

 

Conclusion: It is hypothesized that HI-FRM and FL combination treatment may be effective in improving wrinkles, texture and pigmentation of the face and/or neck.