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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PicoWay 532nm fractional treatment | Experimental | subjects will receive one treatment for peri auricular and/or Buttocks by 532nm hand-piece |
|
| PicoWay 1064nm fractional treatment | Experimental | subjects will receive one treatment for peri auricular and/or Buttocks by 1064nm hand-piece |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PicoWay 532nm fractional treatment | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | day 0 up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 0 and at 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arielle Kauvar, MD | NY Laser Skin Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arielle N. Kauvar, | New York | New York | 10028 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19916261 | Background | Brightman L, Goldman MP, Taub AF. Sublative rejuvenation: experience with a new fractional radiofrequency system for skin rejuvenation and repair. J Drugs Dermatol. 2009 Nov;8(11 Suppl):s9-13. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 23, 2018 | |
| Reset | Sep 19, 2018 | |
| Release | Sep 25, 2018 | |
| Reset | Oct 22, 2018 | |
| Release | Oct 29, 2018 | |
| Reset | Nov 29, 2018 | |
| Release | Jun 17, 2019 | |
| Reset | Jul 10, 2019 | |
| Release | Dec 16, 2019 | |
| Reset | Jan 6, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 23, 2018 | Sep 19, 2018 | |||
| Sep 25, 2018 |
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|
| PicoWay 1064nm fractional treatment | Device | 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 |
|
|
| Observation of erythema/edema after treatment | Observation of erythema/edema after treatment via clinical skin assessment | 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 | 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 | 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 | day 0, up to 7 months |
| Oct 22, 2018 |
| Oct 29, 2018 | Nov 29, 2018 |
| Jun 17, 2019 | Jul 10, 2019 |
| Dec 16, 2019 | Jan 6, 2020 |