Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT02700204
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2016-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
Sponsor:
Syneron Medical
Organization:
Study Overview
Official Title:
Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: