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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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
Arielle N. Kauvar,
New York, New York, United States
To collect skin biopsies after fractional PicoWay treatments
To collect skin biopsies after fractional PicoWay treatments to evaluate depth and damage caused by laser induced optical breakdown (LIOB)
Time frame: day 0 up to 2 months
Histological evidence of LIOBs and location of LIOBs
Histological evidence of LIOBs and location of LIOBs (epidermis or dermis) immediately after treatment or at 48 hours after treatment, with either the 1064nm or 532nm picosecond fractional laser focused at the surface or sub-surface of the peri auricular and/or Buttocks area/s
Time frame: day 0 and at 48 hours
Observation of erythema/edema after treatment
Observation of erythema/edema after treatment via clinical skin assessment
Time frame: day 0 up to 2 months
Histological evidence of an inflammatory response
Histological evidence of an inflammatory response in the dermis immediately after treatment or at 48 hours after treatment that should lead to production of new collagen and elastin
Time frame: at 48 hours
Histological evidence of new collagen growth
Histological evidence of new collagen growth at 2 months after treatment with either a 1064nm or 532nm picosecond fractional laser treatment
Time frame: at 2 months
Number of subjects with adverse events
The number, description, severity, intervention and outcome of any adverse events will be reported on adverse event forms
Time frame: day 0, up to 7 months
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