Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02600104
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction
Sponsor:
Syneron Medical
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites.
Detailed Description:
This is an open-label, multi-center study. Subjects in this study will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
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?: