Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin
Condition: Acne Scars
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The primary objective of this randomized, split-face, controlled study is to compare the
      efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar
      fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars
      in ethnic skin (Fitzpatrick Skin Phototypes III-VI).

      The hypothesis of this study is that both erbium-doped 1,550-nm non-ablative fractional laser
      and the bipolar fractional radiofrequency microneedle device are equally effective for the
      treatment of atrophic acne scars in ethnic skin (SPT III-VI). However, the bipolar fractional
      radiofrequency microneedle device has less adverse effects than erbium-doped 1,550-nm
      non-ablative fractional laser due to the absence of scattering and the absence of
      chromophore-specific targets - predominantly melanin - traditionally needed with laser
      treatments; hence the fractional radiofrequency microneedle device will have a higher safety
      profile in darker skin types .
    

Detailed description: 
      Acne is a highly prevalent disease and post-acne scaring has shown to have detrimental
      effects on a person's physical, mental, and social well-being. Acne scars can be divided in
      general categories of hypertrophic or keloid scars, atrophic scars (icepick, rolling,
      boxcar), and pigmentation alterations (redness, hypo and hyper-pigmentation). This study will
      focus on treatment of moderate to severe grades of atrophic acne scarring. Our aim is to
      compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and
      a bipolar fractional radiofrequency microneedle device for the treatment of atrophic acne
      scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI) by performing a split-face
      randomized controlled trial.

      Both devices in this study are already FDA approved treatment modalities for acne scarring.

      History of erbium-doped 1,550-nm non-ablative fractional laser (Fraxel® Restore Laser System,
      Solta Medical, Inc., Hayward, CA):

      Non-ablative fractional lasers work via the theory of fractional photothermolysis, which
      creates hundreds to thousands of microscopic thermal zones (MTZs), or columns of thermally
      injured skin, while sparing the surrounding tissue. The pixilated nature of treatment and the
      functionally unimpaired stratum corneum allow for rapid tissue healing and allows for safer
      treatments of our patients. Mechanistically, fractional photothermolysis allows controlled
      amounts of high energy to be delivered deep within the dermis resulting in collagenolysis and
      neocollagenesis, which smoothes the textural abnormalities of acne scarring.

      Multiple published studies have demonstrated that erbium-doped 1,550-nm non-ablative
      fractional laser ("NAFL") can be successfully utilized in the treatment of all forms of
      atrophic acne scarring - ice-pick, boxcar, and rolling scars - with a very favorable safety
      profile in all skin types, and thus, has been cleared by Food and Drug Administration (FDA)
      for that particular indication. According to the manufacture manual (reference attached in
      the "Attachments" section), NAFL is indicated for "use in skin resurfacing procedures as well
      as treatment of acne scars, surgical scars, lentigos (age spots), solar lentigos (sun spots),
      actinic keratosis, and melasma."

      History of the fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD
      Ltd., Israel):

      Fractional radiofrequency is not a laser. Instead, these devices use an array of electrodes
      that allows for zones of thermal wounds to be created between areas of unaffected zones, thus
      stimulating dermal remodeling and allowing for a supply of reservoir cells to promote
      healing. Variations of fractional radiofrequency exist that employ microneedles to deliver
      electrical current to a particular depth within the dermis that decreases damage to the
      epidermis. These fractional radiofrequency microneedle devices provide an alternative to
      conventional methods of acne-scar treatment (such as NAFL). Great interest has been
      culminating over the recent years for the use of such devices in acne scars due to the
      absence of light scattering and the absence of chromophore-specific targets traditionally
      needed with laser treatments. As melanin is not a target, it is felt to have a higher safety
      profile in darker skin phototypes.

      A recent study investigated the safety and efficacy of a specific bipolar fractional
      radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel) for acne
      and acne scarring. In this study, 8 patients with acne scars were reported and it was noted
      that all patients (regardless of their skin phototypes) had improvement in their active acne
      and acne scars after 4 treatments and a 1 month, on average follow-up period. The treatment
      was well tolerated without any side-effects. Skin biopsies from this study showed reduction
      in scar depth and new collagen formation with an increase in elastic fibers and adnexal
      structures noted. A follow-up report showed that 4 out of 8 patients who were in the original
      study returned for a long term follow-up from 1 to 2 years, that showed ongoing clinical
      improvements in these patients. This specific bipolar fractional radiofrequency microneedle
      ("FRM") device has been FDA-approved for acne scars and skin rejuvenation.

      To this date the efficacy and safety of 1,550-nm fractionated photothermolysis system has not
      been compared to a fractional radiofrequency microneedle device for atrophic acne scars in
      ethnic skin in a randomized split-face controlled trial. A major advantage of a split-face
      self-controlled design would be to minimize any confounding factors. Laser resurfacing has
      been well studied and is widely used in individuals with fair skin - Fitzpatrick skin
      phototypes (SPT) I to II. However, there is a paucity of published studies involving
      individuals with darker skin types (SPT III-VI)-a population that has a higher risk of
      laser-associated dyspigmentation.
    

Intervention name(s): Fraxel Restore; Fractora
Intervention type(s): Device; Device
Intervention description(s): Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.; Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Randomized split-face clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment