Dyschromia Clinical Trial
Official title:
Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01491620 -
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
|
N/A | |
Completed |
NCT05388604 -
Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging
|
N/A | |
Terminated |
NCT02506101 -
Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo
|
N/A | |
Completed |
NCT02693054 -
Safety and Efficacy Study for Various Skin Conditions
|
N/A |