Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
Condition: Photoaging; Wrinkle
Study type: Interventional

Summary: 
      This randomized, single-center, double-blinded, controlled, clinical trial was conducted to
      investigate the tolerability, safety, and efficacy of a post-procedure cream when used
      immediately after radiofrequency microneedling and for seven days post-procedure with twice
      daily application in healthy female subjects ages 35-65 with moderate facial photodamage
      (Grade II or III) using the Glogau Scale of Photoaging. Furthermore, this clinical trial will
      compare the active post-procedure cream to a comparator anhydrous cream product often paired
      with skin rejuvenation procedures.

      A total of 11 healthy female subjects completed the study. Six (6) subjects in the active arm
      and five (5) subjects in the comparator arm.
    

Detailed description: 
      This randomized, single-center, double-blinded, controlled, clinical trial was conducted to
      investigate the tolerability, safety, and efficacy of a post-procedure cream when used
      immediately after radiofrequency microneedling and for seven days post-procedure with twice
      daily application in healthy female subjects ages 35-65 with moderate facial photodamage
      (Grade II or III) using the Glogau Scale of Photoaging in improving patient downtime
      specifically in minimizing tolerability parameters (erythema, edema, dryness, burning,
      stinging, and itch) to assist in soothing skin after radiofrequency microneedling procedure.

      A 7-day washout period is required for all subjects prior to radiofrequency microneedling
      procedure. Tolerability (investigator and subject) and safety will be assessed through
      grading at baseline, post-procedure, post-procedure/post-product application, twenty-four
      (24) hours post-procedure, three days post-procedure, and seven days post-procedure.

      Tolerability parameters included erythema, edema, dryness, burning, stinging, and itch.
      Efficacy evaluation using the Glogau photoaging scale was performed at screening, baseline,
      and day 7 post-procedure. The Global Aesthetic Improvement Scale (GAIS) was performed at day
      7-post procedure. Self-assessment questionnaire and clinical photography will be completed at
      all timepoints.

      A total of 11 subjects completed study participation. Six (6) subjects in the active arm and
      five (5) subjects in the comparator arm.
    

Intervention name(s): Radiofrequency Microneedling; Facial Cleanser; Facial Moisturizer; Sunscreen
Intervention type(s): Procedure; Other; Other; Other
Intervention description(s): A fractional bipolar radiofrequency microneedling device will be performed at Visit 2, after the 7-day washout period. Subjects were numbed 45 minutes prior to RF microneedling with topical numbing Benzocaine 20%/Lidocaine 6%/tetracaine 4%. Bony areas, periorbital, forehead, and chin were treated with 15 watts at a 2 mm needle depth on cycle mode. All subjects received 20 watts at 3 mm depth on cycle mode on soft tissue, neck, and cheeks.; Facial cleanser to be used by subjects twice-daily. This product was used during the entire 14-day study (7-day washout period and 7-day post-procedure timeline).; Bland moisturizer to be used by subjects twice daily during the 7-day washout period. Use 1 to 2 pumps and place all over face and avoid the eye area.; Bland sunscreen to be used by subjects after cleansing and the facial moisturizer during the 7-day washout period. Bland sunscreen to be used by subjects after cleansing and after the active post-procedure cream and comparator anhydrous cream. Use the provided sunscreen and reapply as needed throughout the day and per recommendation of the FDA, every 2 hours.
Other intervention name(s): Fractional biopolar radiofrequency microneedling, InMode; Neutrogena Sheer Zinc SPF 50
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single-center, double-blinded, controlled.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: post-procedure; radiofrequency microneedling