Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
Condition: Dyschromia
Study type: Interventional

Summary: 
      This is an open-label, two-arm, histological evaluation study.

      Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to
      receive PicoWay fractional treatment:

      Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri
      auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece

      All subjects will have biopsies from the treated area:

        -  at baseline prior to treatment;

        -  immediately after treatment (within 30 minutes) or 48 hours after treatment;

        -  2 months after treatment. Methodology described in the protocol to evaluate efficacy and
           safety of treatments will be carried out at each visit at the clinic.
    

Detailed description: 
      This histological study is a prospective clinical study to evaluate skin biopsies after a
      single PicoWay treatment with the 532nm or 1064nm fractional hand-piece.

      Up to 30 healthy candidates, will be enrolled at up to 2 participating study sites. Subjects
      in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive
      fractional treatment for peri auricular and/or Buttocks according to investigator decision:

      Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece

      Subjects will receive one treatment for peri auricular and/or Buttocks, with the fractional
      hand-piece. The investigator may use a multiplicity of energy levels in area or subarea in a
      single treatment, in order to titrate the optimum energy level. Further, if the investigator
      elects to, the Picoway handpiece can have at its distal end (at the distance gauge ending) a
      flat piece of a transparent plastic/glass (with appropriate anti reflective coating if
      desired), which will be in contact with the skin. In this case, the investigator may also
      elect to use a coupling gel as a matching medium between the skin and the glass.

      All subjects will have biopsies of the treated area (a single or two peri or post-auricular,
      buttocks) at baseline prior to treatment. Biopsies from each area will also be performed
      immediately after treatment (within 30 minutes) and/or at ~48 hours after treatment,
      according to physician discretion, and at the 2-month follow-up.

      Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment
    

Intervention name(s): PicoWay 532nm fractional treatment; PicoWay 1064nm fractional treatment
Intervention type(s): Device; Device
Intervention description(s): is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps; is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps
Other intervention name(s): PicoWay Resolve 532nm handpiece; PicoWay Resolve 1064nm handpiece
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment